QRA Medical

Quality & Regulatory Affairs Consultancy Services

Founder

The Medtech Podcast

Founder & Host

BioExpert Network

MedTech Expert

Hegenberger Medical - Transforming postpartum suturing.

Quality and Regulatory Consultant

UKMEDI - UK Disposable Medical Supplies

Advisory Board Member

Be the Business

AIVF

Hardian Health

Quality and Regulatory Affairs Consultant

Mphasis

Quality & Regulatory Consultant

30 TECHNOLOGY

Regulatory Affairs Consultant

Do you need help legally bringing your medical device to market in the UK, EU or USA? Feel free to send me a message to see how we can work together on achieving this 📧

Using my extensive knowledge of scientific, legal and business issues acquired throughout different aspects of my work, my main role is to ensure the appropriate licensing, marketing and legal compliance of medical devices to make sure that they reach the end consumer safely. 

I see myself as a crucial link between the industry and the general public; as their bridge of trust to ensure that the medical products that they use are of a high quality standard and meet every guideline there is. 

Moving forward, I am always willing to meet people from both the medical and healthcare industry to share their experiences and stories. If you take an interest to what I do or wish to contact me for business and/or other opportunities, please feel free to connect with me

Book a Microconsulting call with me: https://calendly.com/karandeepbadwal/microconsulting

Functional Areas of Focus:
- Medical Devices (ISO 13485, ISO 14971, MDR, Quality Management Systems, Technical File Remediation, ISO 11607, ISO 14644, IQ OQ, PQ, FDA CFR 21, GMP, 510k, IEC 62304, IEC 82304, Complaint Handling, CAPA, Sterilisation, Software Validation, Computer System Validation CSV, eQMS, Article 10(9)
- Regulatory Affairs (RA)
- Quality Assurance (QA/QC)
- Medtech (SaMD, Digital Health, Artificial Intelligence/AI, Machine Learning)
- PRRC (Person Responsible for Regulatory Compliance) 
- UKRP (UK Responsible Person)
- eQMS (Qualio, Greenlight Guru, JIRA, Atlassian, G Suite, Confluence, Mastercontrol)
- Certified ISO 13485 QMS Auditor (CQI/IRCA)
- Certified EU MDR Practitioner (CQI/IRCA)
- UKCA, CE, FDA, 510k, PMA, De Novo

My Content:
- How to build an ISO 13485 Quality Management System: Tinyurl.com/yagnzxm7
- ISO 13485 or ISO 9001 Quality Management Systems: Tinyurl.com/yavjg6kq
- Medical Device CAPA (Corrective Action and Preventative Action): Tinyurl.com/ycqubsba
- ISO13485 V FDA CFR 21 Part 820: Tinyurl.com/y94bkf5w
- How To Obtain A European CE Mark: Tinyurl.com/yxzplrr2
- What is UKCA and UKRP: Tinyurl.com/cus6teyy 
- What is an EC REP: https://tinyurl.com/59durub8

Follow me on YouTube @KarandeepBadwal

Follow my Podcast @The MedTech Podcast: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3

𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗵𝗼𝗺𝗲?

Today as I was brushing my teeth I noticed my toothpaste had the MD symbol making it a medical device alongside a 4-digit number to its CE Mark indicating to me it is above a Class I. To make such claims for a Toothpaste can be Tenuous depending on the intended use

What other medical devices have you noticed in your home?

Karandeep Singh Badwal

𝗧𝗵𝗲 𝗘𝗨 𝗠𝗗𝗥 𝗲𝘅𝘁𝗲𝗻𝘀𝗶𝗼𝗻 𝗮𝗹𝗹𝗼𝘄𝘀 𝘆𝗼𝘂 𝘂𝗽 𝘂𝗻𝘁𝗶𝗹 𝟯𝟭𝘀𝘁 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟳 𝗼𝗿 𝟮𝟬𝟮𝟴 𝗼𝗻𝗹𝘆 𝗶𝗳 𝘆𝗼𝘂 𝗵𝗮𝘃𝗲 𝗮 𝘀𝗶𝗴𝗻𝗲𝗱 𝗰𝗼𝗻𝘁𝗿𝗮𝗰𝘁 𝗶𝗻 𝗽𝗹𝗮𝗰𝗲 𝗯𝘆 𝟮𝟲𝘁𝗵 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰!

The EU MDR extension period currently allows for MDD certified Class III devices and Class IIb implantables to be placed on the market until 31st December 2027, for Class IIb, IIa and I the date is 31st December 2028. According to the MDR amendment proposal Devices may be placed on the market until the extended period 𝗼𝗻𝗹𝘆 𝗶𝗳 𝗮𝗹𝗹 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝗮𝗿𝗲 𝘀𝗮𝘁𝗶𝘀𝗳𝗶𝗲𝗱:

1. 𝗕𝘆 𝟮𝟲𝘁𝗵 𝗠𝗮𝘆 𝟮𝟬𝟮𝟰, the manufacturer must have in place a Quality Management System in accordance with Article 10(9) of the EU MDR
2. 𝗕𝘆 𝟮𝟲𝘁𝗵 𝗠𝗮𝘆 𝟮𝟬𝟮𝟰, the manufacturer or their authorised rep must have lodged a formal application in accordance with section 4.3, first subparagraph, of Annex VII for conformity assessment 
3. 𝗕𝘆 𝟮𝟲𝘁𝗵 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰, the notified body and the manufacturer must have a signed written agreement in accordance with section 4.3, first subparagraph, of Annex VII for conformity assessment 

So in short this wasn't so much of an extension but a bit of breathing room for those who could not secure a notified body, if you haven't already done so, 𝗴𝗲𝘁 𝘆𝗼𝘂𝗿 𝗰𝗼𝗻𝘁𝗿𝗮𝗰𝘁 𝗶𝗻 𝗽𝗹𝗮𝗰𝗲!

#EUMDR #MDR #NotifiedBodies #MedicalDevices 

𝗛𝗮𝗽𝗽𝘆 𝗩𝗮𝗶𝘀𝗮𝗸𝗵𝗶 𝟮𝟬𝟮4 𝘁𝗼 𝗮𝗹𝗹 𝘁𝗵𝗼𝘀𝗲 𝗰𝗲𝗹𝗲𝗯𝗿𝗮𝘁𝗶𝗻𝗴 𝘁𝗼𝗱𝗮𝘆!

For those of you in my network who may not know, Vaisakhi is a day to celebrate 1699 the year when Sikhism was born as a faith. On March 30th 1699, an exemplary model of a good human being was created. It was the first day in the month of Vaisakh - coinciding with a time of blossom and rejuvenation of nature.

A Baptised Sikh was deemed to possess utter humility, compassion, steadfastness, selflessness, altruism, ascending optimism, truth, equanimity, commitment to civic responsibility, contentment and love.

Excited to share my experience attending Barcelona 2023! 

🌟 It was an incredible opportunity to connect with industry leaders and emerging companies in the dynamic field of #MedTech. The event showcased cutting-edge innovations and fostered valuable networking opportunities. 

From insightful panels to interactive sessions, LSI Barcelona offered a platform to explore the latest trends and forge meaningful connections. Can't wait for this year's event! 

In the picture with me is Chris Kennedy of Prolucid Technologies who I am sure will share a few interesting stories of what we got up to 😅

#LSIBarcelona #MedTechInnovation #NetworkingOpportunity #MedTech

🚀 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗖𝗔𝗣𝗔𝘀 𝗪𝗼𝗿𝗸: 𝗕𝗲𝗰𝗮𝘂𝘀𝗲 𝗡𝗼𝗯𝗼𝗱𝘆 𝗪𝗮𝗻𝘁𝘀 𝗣𝗿𝗼𝗯𝗹𝗲𝗺𝘀 𝘁𝗼 𝗕𝗼𝗼𝗺𝗲𝗿𝗮𝗻𝗴 🔄

The unsung heroes of the Quality Assurance world – CAPAs (Corrective and Preventive Actions) making sure everything runs smoothly. 

However without the all-important "Effectiveness Checks" and "Validation," your CAPAs might just boomerang the problem back to you in the future

Picture this: You've dealt with a non-conformance, summoned your trusty CAPAs, and thought, "Good riddance!" But lo and behold, a few months down the line, it's back! 

That's where "Effectiveness Checks" come into play. These checks are the Sherlock Holmes of CAPAs, ensuring that the problems stay gone for good! 🕵️‍♂️

Although those diligent CAPA effectiveness checks and validations may seem like common sense and not worth doing. They're essential in preventing problems from returning in any unexpected shape or form. 

Remember, what is the point in spending time implementing CAPAs then leaving out the final stages to ensure the action was effective and validating it over time?

Original post credit to EU MDR Compliance - https://lnkd.in/eDUnSp4m

#QualityAssurance #CAPAs #EffectivenessChecks #Validation 

𝗬𝗼𝘂 𝗮𝗿𝗲 𝗮 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗲𝘅𝗽𝗲𝗿𝘁 𝗯𝘂𝘁 𝘄𝗵𝗮𝘁 𝘀𝗸𝗶𝗹𝗹 will 𝗺𝗮𝗸𝗲 𝘆𝗼𝘂 𝗮 𝗺𝗮𝘀𝘁𝗲𝗿? 
 
In the labyrinth of medical devices, quality, and regulatory affairs, knowledge is your compass. Yet, knowing is only half the battle. The true challenge? Illuminating the path for others. 
 
Imagine being the beacon in your organization, guiding your team through the dense regulations and quality standards. But what if your beacon flickers? What if your message gets lost in translation? Without the power to teach, to clearly convey your expertise, compliance becomes a mirage. 
 
𝗛𝗲𝗿𝗲'𝘀 𝘁𝗵𝗲 𝘀𝗲𝗰𝗿𝗲𝘁 𝘀𝗮𝘂𝗰𝗲: 𝗯𝗲𝗰𝗼𝗺𝗶𝗻𝗴 𝗮 𝗺𝗮𝘀𝘁𝗲𝗿𝗳𝘂𝗹 𝘁𝗲𝗮𝗰𝗵𝗲𝗿. 
 
Teaching is not just about imparting knowledge. It's about opening minds, sparking curiosity and fostering collaboration. When you teach, you don't just share your knowledge; you multiply it. You invite questions, encourage debate, and, most importantly, you learn. Yes, the act of teaching deepens your own understanding, embedding your expertise even further. 
 
So, how do you become this great teacher? Start with empathy. Remember, not everyone speaks 'regulatory'. Tailor your message, make it accessible and suddenly, you're not just a professional; you're a mentor, a guide, a leader. 
 
The beauty of teaching is in its reciprocity. As you illuminate the way for others, you'll find your own understanding enriched, your collaborations strengthened and your compliance strategies more robust. 
 
Share your insights, engage in dialogue, and watch as the walls of confusion crumble to reveal a team united in clarity and purpose. 
 
 
 
 

No alternative text description for this image

🚀 𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝗹𝗮𝘂𝗻𝗰𝗵 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝘀𝘁𝗮𝗿𝘁𝘂𝗽 𝗶𝗻 𝘁𝗵𝗲 𝗨𝗦𝗔? 𝗛𝗼𝘄 𝗹𝗼𝗻𝗴 𝗱𝗼𝗲𝘀 𝗶𝘁 𝘁𝗮𝗸𝗲? 
 
It can vary in terms of timelines, depending on the device class. Class 1 devices get the green light fastest, while Class 3 plays the waiting game.  
 
The majority of Class 1 devices are not required to undergo the 510(k) clearance process. These devices, which are typically low-risk and already approved for sale, encompass non-invasive products like tongue depressors, oxygen masks, and electric toothbrushes. 
 
Approximately 43% of medical device submissions are categorized as Class 2, representing moderate-risk devices like contact lenses, syringes, and catheters. Most Class 2 devices typically necessitate a 510(k) application process, wherein manufacturers establish the safety and effectiveness of their device by demonstrating substantial equivalence to a previously approved device. 
 
Under the traditional 510(k) pathway, the average clearance time spans 177 days, or almost six months, with only 19% of devices cleared within three months. 
 
The majority of Class 3 devices undergo the PMA pathway, which is the most rigorous type of application involving scientific and regulatory review by the agency. This pathway requires presenting substantial scientific evidence to demonstrate the device's safety and effectiveness. 
 
While preparing a PMA application is typically more rigorous than a 510(k) application or self-registration, the wait time post-submission isn't significantly longer. According to an agency report, the average approval time for a PMA application is 243 days after submission, slightly over eight months, which is 66 days longer than the average approval time for a 510(k) application. 
 
🏁 It's important to recognize that the FDA can be a collaborative partner if given the opportunity. Their aim is to facilitate the swift market entry of innovative and safe devices, and they've enhanced accessibility to expedite approvals. Adopting an outdated approach and merely meeting minimum requirements based on assumptions can lead to setbacks. Once trust in your intentions with the FDA is compromised, repercussions can be severe. Embrace openness and collaboration and leverage their newer "interactive" review approach for better outcomes. 
 
 
 

As the Easter break begins the sun has come out in the UK and will remain so over the weekend 🌞

Only means one thing for me the classics can finally hit the road, look forward seeing the roads being filled again with anything from old school fords, british leyland and the odd american 70s muscle.

For those interested this is my rolling restoration 1990s Mercedes 230CE with a few tasteful factory AMG modifications

𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝘁𝗼 𝗲𝗻𝘁𝗲𝗿 𝘁𝗵𝗲 𝗦𝗮𝘂𝗱𝗶 𝗔𝗿𝗮𝗯𝗶𝗮𝗻 𝗺𝗮𝗿𝗸𝗲𝘁? 🇸🇦 
 
Ready to launch your medical devices in Saudi Arabia? 🚀 Here's the simplified process for SFDA Approval! 🏥 
 
🔍 Understand device classification 
🙋‍♂️ Appoint a KSA Authorized Representative 
📂 Prepare a Technical File 
📝 Submit your application 
💰 Pay the fee 
📜 Receive your Medical Device Marketing Authorization certificate upon approval (MDMA) 
 
Of course, this is a very simplified version of the process as a whole, I always recommend speaking with an experienced professional before going through this process. Remember the penultimate step prior to submission should always be to double check your technical file is up to scratch, this will often be your limiting step in terms of timelines if there are issues! 
 
#SFDA #SaudiArabia #Saudi #MedicalDevices #Regulatory

𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗪𝗮𝘁𝗲𝗿𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 🚢 
 
Ever found yourself pondering over the classification of a medical device? Perhaps while holding a seemingly simple product, like eye drops and wondering about its regulatory standing. You're not alone. Understanding the classification of medical devices is crucial but it can often seem like deciphering hieroglyphs. 
 
Here's a brief guide to help demystify the process: In many jurisdictions, including those regulated by the FDA (U.S. Food and Drug Administration) or under the MDR (Medical Device Regulation) in the EU, medical devices are categorized based on their risk level to patients and users. These range from Class I (low risk) to Class III (high risk). Factors influencing classification include invasiveness, duration of contact with the body and whether they are active or non-active devices etc. 
 
A place to start is with a strong intended use statement, many I review are often Tenuous and not very clear 
 
Now, regarding eye drops: They could be classified differently based on their intended use and mechanism of action. For example, if they provide lubrication only with no therapeutic claims, they might be considered lower risk compared to those claiming to treat or prevent eye conditions.  
 
Understanding these classifications isn't just bureaucratic compliance; it's about ensuring safety and efficacy in products that impact health outcomes. 


𝗔𝗿𝗲 𝘆𝗼𝘂 𝗼𝘃𝗲𝗿𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝘃𝗲 𝗽𝗼𝘄𝗲𝗿 𝗼𝗳 𝗰𝗼𝗻𝘁𝗲𝗻𝘁 𝗶𝗻 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘀𝗲𝗰𝘁𝗼𝗿? 🤔 
 
As a Quality & Regulatory Consultant , I've noticed a trend: there's a lingering scepticism around the value of content creation within our industry. But allow me to challenge this notion with an insightful perspective that just might shift your viewpoint. 
 
Content, especially in niches as specialised as Medical Devices, Quality and Regulations of which can be variegated at times, acts not just as a tool for engagement but as a vessel for demonstrating expertise and authority.  
 
The heart of effective content marketing lies far beyond motivational quotes or personal anecdotes. It’s about crafting narratives that resonate with your audience's professional challenges and aspirations. Through sharing deep industry insights, regulatory updates or quality benchmarks, you contribute significantly to the collective knowledge pool - establishing yourself as a beacon within the medical device community. 
 
Our industry is ripe for leaders who are ready to share their wisdom and mould the future of healthcare through engaging dialogue and insightful analysis. Will you rise to the occasion?  

𝗗𝗲𝗺𝘆𝘀𝘁𝗶𝗳𝘆𝗶𝗻𝗴 𝗔𝗜 𝗮𝗻𝗱 𝗧𝗲𝗹𝗲𝗵𝗲𝗮𝗹𝘁𝗵 𝗖𝗼𝗺𝗺𝗼𝗻 𝗠𝗶𝘀𝗰𝗼𝗻𝗰𝗲𝗽𝘁𝗶𝗼𝗻𝘀 𝗗𝗲𝗯𝘂𝗻𝗸𝗲𝗱

A snippet from The Medtech Podcast Episode 65 with Christa Natoli (She/Her) Executive Director at Center for Telehealth and Ehealth Law CTeL, a digital health research institute focused on telehealth, remote monitoring, and AI

Christa has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker 

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare

𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀:

Apple Podcasts: https://lnkd.in/d2F42zJT
Spotify: https://lnkd.in/dpejUHxt
Anchor FM: https://lnkd.in/dyQKbzAr
Google Podcast: https://lnkd.in/daniXPaj
Amazon Music: https://lnkd.in/gAzcqw-x
Stitch: https://lnkd.in/gVvJvv_N
RadioPublic: https://lnkd.in/gXcdv2MN  

If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal 

#AI #DigitalHealth #Telehealth #Healthcare #Connectivity

𝗜𝗺𝗽𝗿𝗼𝘃𝗶𝗻𝗴 𝗜𝗻𝘁𝗲𝗿𝗻𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀 𝗶𝗻 𝗥𝗲𝗺𝗼𝘁𝗲 𝗔𝗿𝗲𝗮𝘀 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗖𝗼𝗻𝗻𝗲𝗰𝘁𝗶𝘃𝗶𝘁𝘆 𝗮𝗻𝗱 𝗔𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆

A snippet from The Medtech Podcast Episode 65 with Christa Natoli (She/Her) Executive Director at Center for Telehealth and Ehealth Law CTeL, a digital health research institute focused on telehealth, remote monitoring, and AI

Christa has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker 

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare

𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀:

Apple Podcasts: https://lnkd.in/d2F42zJT
Spotify: https://lnkd.in/dpejUHxt
Anchor FM: https://lnkd.in/dyQKbzAr
Google Podcast: https://lnkd.in/daniXPaj
Amazon Music: https://lnkd.in/gAzcqw-x
Stitch: https://lnkd.in/gVvJvv_N
RadioPublic: https://lnkd.in/gXcdv2MN  

If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal 

#AI #DigitalHealth #Telehealth #Healthcare #Connectivity


𝗘𝘃𝗲𝗿 𝘁𝗵𝗼𝘂𝗴𝗵𝘁 𝗮 𝘁𝗶𝗻𝘆 𝗼𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁 𝗰𝗼𝘂𝗹𝗱 𝗰𝗼𝘀𝘁 𝗺𝗶𝗹𝗹𝗶𝗼𝗻𝘀? 𝗜𝗻 𝘁𝗵𝗲 𝘄𝗼𝗿𝗹𝗱 𝗼𝗳 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀, 𝗶𝘁'𝘀 𝗮 𝗿𝗲𝗮𝗹𝗶𝘁𝘆. 
 
𝗠𝗶𝘀𝘁𝗮𝗸𝗲 𝟭: Viewing compliance as a checkbox exercise. It's not just about meeting standards; it's about embedding quality in every fibre of your organisation. 
 
𝗠𝗶𝘀𝘁𝗮𝗸𝗲 𝟮: Underestimating the power of data. In an era where precision is paramount, ignoring data analytics can be the Achilles' heel for Quality Management Systems. 
 
𝗠𝗶𝘀𝘁𝗮𝗸𝗲 𝟯: Skimping on training. When the stakes are potentially life and death, every team member's understanding of QMS needs to be nothing short of impeccable. 
 
𝗠𝗶𝘀𝘁𝗮𝗸𝗲 𝟰: Sticking to the old ways. Innovation isn't just for your products. It's also for the processes that ensure their quality. 
 
𝗠𝗶𝘀𝘁𝗮𝗸𝗲 𝟱: Failing to see the forest from the trees. A Quality Management System isn't just about avoiding errors; it's about building a culture that strives for excellence. 
 
Engage below with your strategies or challenges. What mistakes do you see? 

𝗢𝗻𝗲 𝘀𝗺𝗮𝗹𝗹 𝗵𝗮𝗰𝗸 𝘄𝗵𝗶𝗰𝗵 𝗺𝗮𝘆 𝗺𝗮𝘀𝘀𝗶𝘃𝗲𝗹𝘆 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝘆𝗼𝘂𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝘃𝗶𝘁𝘆 📈 
 
Imagine transforming your workday, not with endless coffee cups ☕, but with a burst of energy that lasts. The secret? Swapping evening sweat sessions for a morning/midday recharge.  
 
I discovered an unexpected productivity hack that's about more than just physical health. By hitting the gym or attending a cardio class during working hours, I've not only boosted my fitness levels but also supercharged my work productivity.  
 
Here's the twist: during the day, your energy levels are naturally higher, both mentally and physically. This means pushing yourself a bit further is not just possible, but enjoyable. The result? A more intense workout and a rush of endorphins that powers you through the afternoon slump.  
 
But there's more. With workouts checked off the list by lunchtime, evenings become a canvas for creativity, quality time with family and friends or even catching up on work. It's like gaining extra hours in your day.  
 
And let's talk about the gym during working hours - quieter, less crowded and with unfettered access to your favourite equipment. It's efficiency at its best. 
 
So, if your work allows for it, why wait until the evening when you can unlock your peak productivity now?  
 
Challenge yourself to a midday workout and feel the difference, not just in your body, but in your work and personal life. 

𝗬𝗼𝘂𝗿 𝗴𝗿𝗮𝘀𝗽 𝗼𝗻 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗺𝗶𝗴𝗵𝘁 𝗯𝗲 𝗺𝗼𝗿𝗲 𝘁𝗲𝗻𝘂𝗼𝘂𝘀 𝘁𝗵𝗮𝗻 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸 🤔 
 
Many of us have sat through the mandatory training and perhaps even pursued the certificates. It's akin to passing your driving test and clutching that fresh license. But here's a thought – 𝘥𝘰𝘦𝘴 𝘵𝘩𝘢𝘵 𝘱𝘪𝘦𝘤𝘦 𝘰𝘧 𝘱𝘢𝘱𝘦𝘳 𝘵𝘳𝘶𝘭𝘺 𝘴𝘪𝘨𝘯𝘪𝘧𝘺 𝘤𝘰𝘮𝘱𝘦𝘵𝘦𝘯𝘤𝘦? 
 
Consider driving for a moment. Does a license make you a good driver, or is it the myriad of experiences on the road? The close calls, the long drives in pouring rain, the unexpected detours? 
 
Similarly, understanding a Quality Management System goes beyond the basics. It's not just about the 'what' but the 'how'. It's applying principles in varying, often challenging environments. It's adapting to new technologies, regulations, and customer expectations. 
 
Real competence in Quality Management Systems comes from experience. From learning to navigate through 'real-world' scenarios that no textbook or classroom can fully prepare you for. It's about making mistakes, learning from them, and continuously improving. 
 
So ask yourself, are you truly experienced drivers in the realm of Quality Management, or just license holders? 
 
Let me know your thoughts 💭 

Christa Natoli (She/Her) Executive Director at Center for Telehealth and Ehealth Law CTeL has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker 

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare

The podcast is available on all major platforms including but not limited to Apple Podcast, Google Podcast, Anchor and Spotify

If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal
 
 #AI #DigitalHealth #Telehealth #Healthcare #Connectivity

Christa Natoli (She/Her) Executive Director at Center for Telehealth and Ehealth Law (CTeL) has extensive policy experience and knowledge in the areas

Open article: #65 Revolutionizing Healthcare through Telehealth, AI and Digital Health with Christa Natoli by Karandeep Singh Badwal • 1 min read

Karandeep Singh Badwal on LinkedIn • 1 min read

#65 Revolutionizing Healthcare through Telehealth, AI and Digital Health with Christa Natoli

𝗧𝗲𝗹𝗲𝗵𝗲𝗮𝗹𝘁𝗵 𝗵𝗮𝘀 𝗯𝗲𝗲𝗻 𝗮𝗿𝗼𝘂𝗻𝗱 𝗮 𝗹𝗼𝘁 𝗹𝗼𝗻𝗴𝗲𝗿 𝘁𝗵𝗮𝗻 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸? NASA - National Aeronautics and Space Administration 𝘀𝗽𝗲𝗮𝗿𝗵𝗲𝗮𝗱𝗲𝗱 𝘁𝗵𝗶𝘀 𝗶𝗻 𝘁𝗵𝗲 𝟲𝟬𝘀

A snippet from The Medtech Podcast Episode 65 with Christa Natoli (She/Her) Executive Director at Center for Telehealth and Ehealth Law CTeL, a digital health research institute focused on telehealth, remote monitoring, and AI

Christa has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker.

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare.

𝗧𝗵𝗲 𝗽𝗼𝗱𝗰𝗮𝘀𝘁 𝗶𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗮𝗹𝗹 𝗺𝗮𝗷𝗼𝗿 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗯𝘂𝘁 𝗻𝗼𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝘁𝗼 𝗔𝗽𝗽𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗚𝗼𝗼𝗴𝗹𝗲 𝗣𝗼𝗱𝗰𝗮𝘀𝘁, 𝗔𝗻𝗰𝗵𝗼𝗿 𝗮𝗻𝗱 𝗦𝗽𝗼𝘁𝗶𝗳𝘆 𝘃𝗶𝗮 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗹𝗶𝗻𝗸𝘀:

Apple Podcasts: https://lnkd.in/d2F42zJT
Spotify: https://lnkd.in/dpejUHxt
Anchor FM: https://lnkd.in/dyQKbzAr
Google Podcast: https://lnkd.in/daniXPaj
Amazon Music: https://lnkd.in/gAzcqw-x
Stitch: https://lnkd.in/gVvJvv_N
RadioPublic: https://lnkd.in/gXcdv2MN  

If there are any particular guests or topics you would like for us to cover in future episodes then get in touch with Karandeep Singh Badwal 

#AI #DigitalHealth #Telehealth #Healthcare #NASA


I am restarting my videos which topics do you want me to cover?



𝗧𝗵𝗶𝗻𝗸 𝘆𝗼𝘂'𝘃𝗲 𝗴𝗼𝘁 𝘆𝗼𝘂𝗿 𝘀𝘁𝗮𝗿𝘁𝘂𝗽'𝘀 𝗷𝗼𝘂𝗿𝗻𝗲𝘆 𝗺𝗮𝗽𝗽𝗲𝗱 𝗼𝘂𝘁 🗺️? 𝗧𝗵𝗶𝗻𝗸 𝗮𝗴𝗮𝗶𝗻.  
 
Navigating the treacherous waters of regulatory compliance is where many bright ideas hit the rocks. And yet, it's often treated as an afterthought. Here's the wake-up call: Integration of regulatory compliance from the get-go isn’t just good practice; 𝘪𝘵’𝘴 𝘢 𝘤𝘰𝘳𝘯𝘦𝘳𝘴𝘵𝘰𝘯𝘦 𝘰𝘧 𝘺𝘰𝘶𝘳 𝘱𝘳𝘰𝘥𝘶𝘤𝘵'𝘴 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭 𝘷𝘪𝘢𝘣𝘪𝘭𝘪𝘵𝘺.  
 
But it's not just about starting early. It's also about breaking out of the silo. A regulatory strategy that doesn't walk hand-in-hand with marketing and reimbursement goals is like a ship without a rudder 🛥️. Directionless.  
 
And here's the curveball – the path to regulatory approval isn't a one-way street. Especially in the realm of medical devices, the regulatory landscape is more akin to navigating the high seas with a map that’s constantly changing. This is where the seasoned expertise of a Regulatory consultant becomes invaluable. Someone who doesn't just know the rules but can play the game, pivoting strategies as new information and perspectives come to light 💡. 
 
So, are you ready to rethink your approach to regulatory compliance?  
   

Taplio

Karandeep Singh Badwal's Linkedin Analytics

Karandeep Singh Badwal

What is Karandeep Singh talking about?

Karandeep Singh Badwal's Best Posts (last 30 days)

Want to drive more opportunities from LinkedIn?

Taplio

.css-1jgreyo{background-image:linear-gradient(284deg, rgba(39,43,72,1) 0%, rgba(33,47,183,1) 100%);color:transparent;-webkit-background-clip:text;background-clip:text;}Karandeep Singh Badwal's Linkedin Analytics

Karandeep Singh Badwal

What is Karandeep Singh talking about?

Karandeep Singh Badwal's Best Posts .css-qqfgvy{font-size:var(--chakra-fontSizes-md);}(last 30 days)

Want to drive more opportunities from LinkedIn?

Karandeep Singh Badwal's Linkedin Analytics

Karandeep Singh Badwal's Best Posts (last 30 days)