QRA Medical

Quality & Regulatory Affairs Consultancy Services

Founder - Quality and Regulatory Consultant

The Medtech Podcast

Founder & Host

BioExpert Network

MedTech Expert

The FDA Group

Quality & Regulatory Consultant

Be the Business

Advisory Board Member

AIVF

Quality and Regulatory Consultant

Hegenberger Medical - Transforming postpartum suturing.

UKMEDI - UK Disposable Medical Supplies

Hardian Health

Quality and Regulatory Affairs Consultant

Mphasis

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

🏆 𝗛𝗼𝗻𝗼𝘂𝗿𝗲𝗱 𝘁𝗼 𝗯𝗲 𝗻𝗼𝗺𝗶𝗻𝗮𝘁𝗲𝗱!

Thrilled to share that QRA Medical has been nominated for “Best Regulatory Strategy Consultancy of the Year” at the MedTech World Awards 2025! 🎉

This recognition means a lot it reflects the hard work, dedication and impact we’ve made supporting MedTech startups and scale-ups through complex EU MDR, IVDR, UKCA and FDA pathways, helping turn breakthrough ideas into market-ready innovations.

A massive thank you to all our clients, partners and peers who continue to trust and collaborate with us this one’s for you 

𝗩𝗼𝘁𝗶𝗻𝗴 𝗶𝘀 𝗻𝗼𝘄 𝗼𝗽𝗲𝗻!
If you’ve found our work helpful, insightful, or inspiring in any way, I’d deeply appreciate your support.

𝗖𝗮𝘀𝘁 𝘆𝗼𝘂𝗿 𝘃𝗼𝘁𝗲 𝗵𝗲𝗿𝗲 - https://lnkd.in/eWiNt3tA

Let’s celebrate the incredible innovation and teamwork shaping the global MedTech ecosystem 🌍

📍 Winners announced at MedTech Malta 2025 Gala Awards, 14th November in Valletta. Join me and many other leaders in the industry there!

#MedTechWorld #MedTechMalta2025 #MedTechAwards #QRAMedical #RegulatoryStrategy #DigitalHealth #MedTechCommunity #HealthcareInnovation

Karandeep Singh Badwal

Talks about #medtech, #healthcare, #digitalhealth, #medicaldevices, and #regulatoryaffairs

MedTech Malta 2025 Gala Awards

Helping MedTech startups unlock EU CE Marking & US FDA strategy in just 30 days ⏳ | Regulatory Affairs Quality Consultant | ISO 13485 QMS | MDR/IVDR | Digital Health | SaMD | Advisor | The MedTech Podcast 🎙️

𝗪𝗵𝗲𝗻 𝘁𝗵𝗲 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 𝗽𝗹𝗮𝗻 𝗹𝗼𝗼𝗸𝘀 𝗽𝗲𝗿𝗳𝗲𝗰𝘁 𝗼𝗻 𝗽𝗮𝗽𝗲𝗿 𝘃𝘀 𝗮𝗳𝘁𝗲𝗿 𝘁𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗱𝗲𝘀𝗶𝗴𝗻 𝗿𝗲𝘃𝗶𝗲𝘄

Left: Samuel-L-Jackson
Right: Samuel-D-Jackson (“D” for Design Freeze fatigue)

Anyone in Medical Devices knows that moment when your smooth Gantt chart meets real-world feedback from clinical, QA and software teams

𝗪𝗲𝗲𝗸 𝟭: “We’ll keep it lean, agile, and aligned to IEC 62304”
𝗪𝗲𝗲𝗸 𝟲: “Wait, that feature changes the intended use…”
𝗪𝗲𝗲𝗸 𝟭𝟬: “We need to redo risk management because marketing updated the claims”

Every project starts as an “L” (logical, linear, lovely) and slowly becomes a “D” (dynamic, delayed, definitely more complex than expected)

But that is not necessarily a bad thing, that’s real design control in action. The key is building flexibility into your process so the inevitable change doesn’t derail compliance.

Because in this industry, your first plan is rarely your final plan. as long as the change is documented, then that is fine!

𝗛𝗼𝗻𝗼𝘂𝗿𝗲𝗱 𝘁𝗼 𝗯𝗲 𝗻𝗮𝗺𝗲𝗱 𝗮𝗺𝗼𝗻𝗴 𝘁𝗵𝗲 𝘁𝗼𝗽 𝘃𝗼𝗶𝗰𝗲𝘀 𝘀𝗵𝗮𝗽𝗶𝗻𝗴 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗠𝗲𝗱𝗧𝗲𝗰𝗵.

Grateful to Amanda Pedersen and the team at Medical Device + Diagnostics Industry MD+DI for the inclusion and inspired to be featured alongside so many individuals whose work continues to elevate our industry.
It’s a privilege to collaborate, learn and grow within such a dynamic global community of innovators.

📖 Read the full feature here: Top 25 Most Influential Voices in MedTech 2025 - https://lnkd.in/eEVV6J_f

🎙️ Big news from the QRA Medical & The Medtech Podcast family!

We’re excited to share that QRA Medical the company powering The MedTech Podcast has been shortlisted for “Best Regulatory Strategy Consultancy of the Year” at the MedTech World Awards 2025! 🏆🎉

👉 Vote Now - https://lnkd.in/eWiNt3tA

This recognition celebrates QRA Medical’s dedication to helping MedTech innovators navigate EU MDR, IVDR, UKCA and FDA pathways accelerating safe and effective products to market.

Read the full story in our latest newsletter 👇

 📰 QRA Medical Nominated for “Best Regulatory Strategy Consultancy of the Year”

#MedTechPodcast #QRAMedical #MedTechWorld #MedTechMalta2025 #RegulatoryStrategy #QualityManagement #DigitalHealth #HealthcareInnovation #MedTechCommunity

🎃 𝗛𝗮𝗽𝗽𝘆 𝗛𝗮𝗹𝗹𝗼𝘄𝗲𝗲𝗻, 𝗠𝗲𝗱𝗧𝗲𝗰𝗵! 👻

For many startups, the scariest monster isn’t lurking under the bed...
It’s the EU MDR chasing them through endless conformity assessments, technical documentation and clinical evaluations

But here’s the reality:
If you build compliance into your design early, even the MDR monster can be tamed. It is not something to be feared

💡 Tip from 100+ successful submissions:
Treat regulatory as a design partner, not a post-launch problem. It’ll save you time, money and a few nightmares.

Stay compliant, stay calm and have a spooktacular Halloween! 🕷️

#MedTech #EUMDR #RegulatoryAffairs #QualityManagement #MedicalDevices #HealthTech #Compliance #Innovation #Startups #HappyHalloween

🚨 𝗜 𝗷𝘂𝘀𝘁 𝗿𝗲𝘃𝗶𝗲𝘄𝗲𝗱 𝟱𝟬+ 𝗙𝗗𝗔 𝘄𝗮𝗿𝗻𝗶𝗻𝗴 𝗹𝗲𝘁𝘁𝗲𝗿𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗽𝗮𝘀𝘁 𝗾𝘂𝗮𝗿𝘁𝗲𝗿.

One pattern jumped out immediately and it wasn’t about complex tech failures or multi-million-dollar systems

It was about something far simpler - 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻

Startups weren’t getting flagged because their devices didn’t work. They were getting flagged because they couldn’t prove they worked. If it is not recorded it did not happen!

• Missing design history files
• Incomplete complaint investigations
• Vague CAPA records
  
All the “boring” stuff that feels like a distraction when you’re sprinting to market. Every shortcut you take with documentation becomes a detour later.

𝗧𝗵𝗿𝗲𝗲 𝘁𝗵𝗶𝗻𝗴𝘀 𝗜 𝘁𝗲𝗹𝗹 𝗲𝘃𝗲𝗿𝘆 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝘀𝘁𝗮𝗿𝘁𝘂𝗽 𝗜 𝘄𝗼𝗿𝗸 𝘄𝗶𝘁𝗵 👇
→ Document in real time — not in hindsight
→ Teach your team: “If it’s not documented, it didn’t happen”
→ Build quality into your process from day one

The winners in MedTech right now aren’t the ones with the biggest compliance budgets, they’re the ones who treat documentation as a competitive advantage

Because your regulatory foundation is either your launch pad or your bottleneck.

Founders in MedTech: What’s been your toughest challenge keeping documentation consistent while moving fast?

“𝗔𝗜 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲: 𝗠𝗼𝗿𝗲 𝗛𝘆𝗽𝗲 𝗧𝗵𝗮𝗻 𝗛𝗲𝗹𝗽?”

After reviewing the EU’s Deployment of AI in Healthcare Report, one thing became very clear most hospitals aren’t being held back by algorithms, but by admin, infrastructure and alignment

𝗛𝗲𝗿𝗲’𝘀 𝗺𝘆 𝗸𝗲𝘆 𝘁𝗮𝗸𝗲𝘄𝗮𝘆𝘀:
• 53% of clinicians spend 20–60% of their time on admin not patient care
• Workforce shortages and IT gaps are a bigger barrier than regulation
• AI developers and clinicians rarely collaborate early, which leads to tools that don’t fit into real-world workflows
• Trust and transparency are still weak points explainability isn’t just a buzzword, it’s what earns adoption
• Without clear ROI and leadership buy-in, AI projects die in “pilot purgatory”

𝗧𝗵𝗲 𝗶𝗿𝗼𝗻𝘆?
EU frameworks like the AI Act, MDR/IVDR and HTAR are already built to support innovation but only for teams who actually integrate regulatory strategy, clinical needs and deployment planning from day one.

At QRA Medical, we help MedTech teams do exactly that turning compliance into a competitive edge and avoiding the “AI hospital pilot graveyard.”

📩 Comment 𝗦𝗧𝗥𝗔𝗧𝗘𝗚𝗬 below, and I’ll share a 30-day framework for building regulatory readiness into your AI roadmap before you even write your next line of code.

1761503680985

🪔 𝗪𝗶𝘀𝗵𝗶𝗻𝗴 𝗲𝘃𝗲𝗿𝘆𝗼𝗻𝗲 𝗮 𝗷𝗼𝘆𝗼𝘂𝘀 𝗗𝗶𝘄𝗮𝗹𝗶 (𝗗𝗲𝗲𝗽𝗮𝘃𝗮𝗹𝗶) 𝗮𝗻𝗱 𝗮 𝗽𝗿𝗼𝘀𝗽𝗲𝗿𝗼𝘂𝘀 𝗕𝗮𝗻𝗱𝗶 𝗖𝗵𝗵𝗼𝗿 𝗗𝗶𝘃𝗮𝘀 (𝗗𝗮𝘆 𝗼𝗳 𝗟𝗶𝗯𝗲𝗿𝗮𝘁𝗶𝗼𝗻)! 🎉

May the Festival of Lights illuminate your path with happiness, success and good fortune

As we celebrate new beginnings, this is also the perfect time to reflect on how we can bring more clarity, structure and light into our own work

For many MedTech startups, regulatory strategy often feels like navigating in the dark, uncertain timelines, unclear classifications and shifting FDA/MDR expectations

At QRA Medical, we help turn that uncertainty into clarity, from defining your intended use and regulatory pathway to getting your device market-ready faster and with fewer surprises

✨ If you’re planning to launch a new device or expand into the EU/US market before 2026, now’s the best time to start aligning your regulatory roadmap

Let’s make sure your next product launch shines as bright as the Diwali diyas!

𝘍𝘰𝘳 𝘵𝘩𝘰𝘴𝘦 𝘪𝘯𝘵𝘦𝘳𝘦𝘴𝘵𝘦𝘥 𝘪𝘯 𝘭𝘦𝘢𝘳𝘯𝘪𝘯𝘨 𝘮𝘰𝘳𝘦 𝘢𝘣𝘰𝘶𝘵 𝘵𝘰𝘥𝘢𝘺. 𝘍𝘰𝘳 𝘏𝘪𝘯𝘥𝘶𝘴, 𝘿𝙞𝙬𝙖𝙡𝙞 𝘮𝘢𝘳𝘬𝘴 𝘵𝘩𝘦 𝘳𝘦𝘵𝘶𝘳𝘯 𝘰𝘧 𝘓𝘰𝘳𝘥 𝘙𝘢𝘮𝘢 𝘵𝘰 𝘈𝘺𝘰𝘥𝘩𝘺𝘢 𝘢𝘧𝘵𝘦𝘳 14 𝘺𝘦𝘢𝘳𝘴 𝘰𝘧 𝘦𝘹𝘪𝘭𝘦 𝘢𝘯𝘥 𝘩𝘪𝘴 𝘷𝘪𝘤𝘵𝘰𝘳𝘺 𝘰𝘷𝘦𝘳 𝘙𝘢𝘷𝘢𝘯𝘢 𝘴𝘺𝘮𝘣𝘰𝘭𝘪𝘴𝘪𝘯𝘨 𝘵𝘩𝘦 𝘵𝘳𝘪𝘶𝘮𝘱𝘩 𝘰𝘧 𝘭𝘪𝘨𝘩𝘵 𝘰𝘷𝘦𝘳 𝘥𝘢𝘳𝘬𝘯𝘦𝘴𝘴 𝘢𝘯𝘥 𝘨𝘰𝘰𝘥 𝘰𝘷𝘦𝘳 𝘦𝘷𝘪𝘭. 𝘏𝘰𝘮𝘦𝘴 𝘢𝘳𝘦 𝘪𝘭𝘭𝘶𝘮𝘪𝘯𝘢𝘵𝘦𝘥 𝘸𝘪𝘵𝘩 𝘥𝘪𝘺𝘢𝘴, 𝘧𝘢𝘮𝘪𝘭𝘪𝘦𝘴 𝘨𝘢𝘵𝘩𝘦𝘳 𝘵𝘰 𝘤𝘦𝘭𝘦𝘣𝘳𝘢𝘵𝘦 𝘱𝘳𝘰𝘴𝘱𝘦𝘳𝘪𝘵𝘺, 𝘢𝘯𝘥 𝘱𝘳𝘢𝘺𝘦𝘳𝘴 𝘢𝘳𝘦 𝘰𝘧𝘧𝘦𝘳𝘦𝘥 𝘵𝘰 𝘎𝘰𝘥𝘥𝘦𝘴𝘴 𝘓𝘢𝘬𝘴𝘩𝘮𝘪 𝘧𝘰𝘳 𝘸𝘦𝘢𝘭𝘵𝘩 𝘢𝘯𝘥 𝘸𝘦𝘭𝘭𝘣𝘦𝘪𝘯𝘨. 𝘍𝘰𝘳 𝘚𝘪𝘬𝘩𝘴, 𝘵𝘩𝘦 𝘥𝘢𝘺 𝘤𝘰𝘪𝘯𝘤𝘪𝘥𝘦𝘴 𝘸𝘪𝘵𝘩 𝘽𝙖𝙣𝙙𝙞 𝘾𝙝𝙝𝙤𝙧 𝘿𝙞𝙫𝙖𝙨, 𝘸𝘩𝘪𝘤𝘩 𝘤𝘰𝘮𝘮𝘦𝘮𝘰𝘳𝘢𝘵𝘦𝘴 𝘵𝘩𝘦 𝘳𝘦𝘭𝘦𝘢𝘴𝘦 𝘰𝘧 𝘎𝘶𝘳𝘶 𝘏𝘢𝘳𝘨𝘰𝘣𝘪𝘯𝘥 𝘚𝘢𝘩𝘪𝘣 𝘑𝘪 𝘧𝘳𝘰𝘮 𝘪𝘮𝘱𝘳𝘪𝘴𝘰𝘯𝘮𝘦𝘯𝘵 𝘢𝘵 𝘎𝘸𝘢𝘭𝘪𝘰𝘳 𝘍𝘰𝘳𝘵, 𝘢𝘭𝘰𝘯𝘨 𝘸𝘪𝘵𝘩 52 𝘤𝘢𝘱𝘵𝘪𝘷𝘦 𝘬𝘪𝘯𝘨𝘴 𝘸𝘩𝘰𝘮 𝘩𝘦 𝘳𝘦𝘧𝘶𝘴𝘦𝘥 𝘵𝘰 𝘭𝘦𝘢𝘷𝘦 𝘣𝘦𝘩𝘪𝘯𝘥. 𝘛𝘩𝘦 𝘎𝘰𝘭𝘥𝘦𝘯 𝘛𝘦𝘮𝘱𝘭𝘦 𝘸𝘢𝘴 𝘭𝘪𝘵 𝘸𝘪𝘵𝘩 𝘭𝘢𝘮𝘱𝘴 𝘵𝘰 𝘤𝘦𝘭𝘦𝘣𝘳𝘢𝘵𝘦 𝘩𝘪𝘴 𝘳𝘦𝘵𝘶𝘳𝘯 𝘵𝘰 𝘈𝘮𝘳𝘪𝘵𝘴𝘢𝘳, 𝘢𝘯𝘥 𝘴𝘪𝘯𝘤𝘦 𝘵𝘩𝘦𝘯, 𝘚𝘪𝘬𝘩𝘴 𝘰𝘣𝘴𝘦𝘳𝘷𝘦 𝘵𝘩𝘦 𝘰𝘤𝘤𝘢𝘴𝘪𝘰𝘯 𝘢𝘴 𝘢 𝘵𝘪𝘮𝘦 𝘰𝘧 𝘧𝘳𝘦𝘦𝘥𝘰𝘮, 𝘤𝘰𝘮𝘱𝘢𝘴𝘴𝘪𝘰𝘯 𝘢𝘯𝘥 𝘴𝘵𝘢𝘯𝘥𝘪𝘯𝘨 𝘶𝘱 𝘧𝘰𝘳 𝘫𝘶𝘴𝘵𝘪𝘤𝘦

"𝗣𝗵𝘆𝘀𝗶𝗰𝗶𝗮𝗻𝘀 𝗟𝗢𝗩𝗘 𝗼𝘂𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁"

Cool story

But here's the thing

Doctors aren't writing the checks

Hospitals are!

And if you don't understand this difference, you're about to waste a LOT of money on a product launch that goes nowhere

I see this ALL the time in MedTech

Founders get amazing feedback from physicians
5-star reviews
Glowing testimonials
"This will change everything"

Then crickets when it's time to sell

Because the person who USES your product and the person who BUYS your product

Two completely different people
Two completely different priorities
Two completely different decision-making processes

Here's what hospitals actually care about

✅ Cost savings (not just "better outcomes")
✅ Integration with existing systems
✅ Compliance and regulatory clearance
✅ Training requirements for staff
✅ Long-term service agreements
✅ Data security and liability

Notice what's NOT on that list

"Do doctors think it's cool"

Your go-to-market strategy needs to speak to BOTH audiences

👉 Clinical validation for the end users
👉 Business case for the decision makers

Miss either one and your product sits on the shelf

If you're a MedTech founder who's getting great clinical feedback but struggling to close hospital deals

You don't have a product problem

You have a positioning problem

And that's exactly what we help fix at QRA Medical

💬 Comment "POSITION" below and I'll send you our free guide: "The 5 Questions Every Hospital Procurement Team Will Ask (And How to Answer Them)"

It's saved our clients months of back-and-forth and thousands in lost opportunities

Jim Foote, CEO and Founder of First Ascent Biomedical a pioneer in functional precision medicine (FPM) that aims to eliminate guesswork from cancer treatment. 
After losing his son to cancer, Jim left a career in cybersecurity to build a data-driven platform that combines AI, robotics and real-time tumour testing to help doctors choose the right therapy for each patient.

In this episode, we explore how FPM differs from traditional genomics-only testing, why tumours can respond differently even with the same patient and how AI can support rather than replace clinicians in treatment decisions. Jim also shares the economic impact of ineffective therapies, the challenges of  scaling regulatory innovation in oncology, and why the future of cancer care  depends on personalisation at the cellular level.

#TheMedTechPodcast #OncologyInnovation #FunctionalMedicine #CancerCare #PrecisionMedicine #AIinHealthcare #HealthTech #ClinicalTrials #PersonalisedMedicine #PatientCentricCare

“𝗜 𝘄𝗮𝗹𝗸 𝗶𝗻𝘁𝗼 𝘀𝗼𝗺𝗲 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗮𝗻𝗱 𝗰𝗮𝗻 𝘁𝗲𝗹𝗹 𝘄𝗶𝘁𝗵𝗶𝗻 𝗳𝗼𝘂𝗿 𝗵𝗼𝘂𝗿𝘀 𝘄𝗵𝗲𝗿𝗲 𝗶𝘁’𝘀 𝗵𝗲𝗮𝗱𝗲𝗱”

The regulatory world isn’t as small as it looks on paper

I recently had a great conversation with a former FDA investigator who’s spent  decades in the trenches auditing medical device and pharma companies across the U.S., Latin America and Europe

We started chatting about inspections and ended up talking about cars, watches and how Lucas electrics ruined British engineering but what really stuck with me was this line:

“𝗜 𝘄𝗮𝗹𝗸 𝗶𝗻𝘁𝗼 𝘀𝗼𝗺𝗲 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗮𝗻𝗱 𝗰𝗮𝗻 𝘁𝗲𝗹𝗹 𝘄𝗶𝘁𝗵𝗶𝗻 𝗳𝗼𝘂𝗿 𝗵𝗼𝘂𝗿𝘀 𝘄𝗵𝗲𝗿𝗲 𝗶𝘁’𝘀 𝗵𝗲𝗮𝗱𝗲𝗱”

When you’ve seen enough systems you feel the health of a QMS before you even open a single SOP and what we both agreed on whether it’s FDA or EU MDR is that too many companies still treat compliance as an afterthought until they’re facing a 483, a warning letter or a Notified Body nonconformity

The irony? The companies that treat regulatory strategy as a business function, not a checkbox, are the ones that actually grow faster, attract investors more easily and spend less time firefighting

If you’re building a device and want to make sure you’re inspection-ready before you’re inspected, I’ve put together my 30-Day Regulatory Strategy Framework, the same process I use to get startups submission-ready fast

Comment 📩 STRATEGY below and I’ll send it over

Jari Närhi, Co-Founder and CEO of NADMED Ltd., a University of Helsinki spin-out revolutionising how we understand and monitor NAD levels. With a background in mechanical engineering and a career spanning medtech, diagnostics and hospital operations, Jari brings a unique systems-level view on cellular health and innovation in clinical testing.

In this episode, we explore why NAD (nicotinamide adenine dinucleotide) is so vital for human health, from fuelling ATP production to supporting DNA repair and immune regulation. Jari breaks down the science of NAD+, NADH, and glutathione and why traditional lab methods like mass spectrometry have long failed to make NAD testing practical or scalable. We discuss the real-world impact of measuring NAD levels, from chronic illness to long COVID, and how this simple test could become as common as checking haemoglobin in the future.

Jari also opens up about NADMED’s regulatory journey, the ethical dilemmas of DIY supplementation, the rise of longevity tech, and how AI will transform personalised diagnostics through pattern recognition in metabolic biomarkers.

#TheMedTechPodcast #NAD #LongevityScience #Biomarkers #Diagnostics #LabInnovation #AIinHealthcare #MetabolicHealth #PersonalisedMedicine #CEIVD

🎙️ Just went live on Perspective 6 Wealth Advisors Podcast with Matthew Nelson, CFP® AIF® ECA, diving deep into what it really takes to get a MedTech startup from concept to market

We covered everything from:
✅ Early regulatory planning as a competitive advantage
💰 Funding realities and why you should triple your expected budget
🏥 How to think beyond regulatory approval to sales and reimbursement
📄 Building a quality system that scales with your company

If you’re a founder, investor or operator building in MedTech, this episode will save you time, money and sleepless nights.

🎧 Listen here:

Apple Podcasts → https://bit.ly/3GGW1Da
Spotify → https://bit.ly/3TofDDW

Big thanks to Matt for such a thoughtful conversation and for shining a light on the realities of building sustainable MedTech ventures.

#MedTech #MedTechStartups #DigitalHealth #HealthTech #MedicalDevices #Funding #RegulatoryStrategy #QualitySystems #Entrepreneurship

🇬🇧 The UK’s Clinical Trials Framework is getting an update

Earlier this month, the MHRA and HRA published their final guidance ahead of major legal changes to how clinical trials will run in the UK from 28 April 2026.

This marks the most significant update since 2004 and it’s designed to make research faster, more transparent, and less burdensome for sponsors and sites.

Here’s what’s changing and why it matters:

𝗕𝗲𝘁𝘁𝗲𝗿 𝗰𝗼𝗼𝗿𝗱𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗠𝗛𝗥𝗔 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗘𝘁𝗵𝗶𝗰𝘀 𝗖𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲𝘀
→ A single, streamlined review process instead of fragmented oversight

𝗚𝗿𝗲𝗮𝘁𝗲𝗿 𝘁𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆 𝗼𝗳 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀
→ Public access to trial decisions and easier data sharing

𝗥𝗲𝗱𝘂𝗰𝗲𝗱 𝗮𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗯𝘂𝗿𝗱𝗲𝗻 𝗳𝗼𝗿 𝘀𝗽𝗼𝗻𝘀𝗼𝗿𝘀
→ Clearer guidance, simpler submissions, and more proportionate safety reporting

𝗔 𝘆𝗲𝗮𝗿 𝗼𝗳 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝘁𝗼 𝗽𝗿𝗲𝗽𝗮𝗿𝗲
→ The new framework takes effect from April 2026, giving researchers time to adapt systems and SOPs

The message is clear: the UK wants to remain a world leader in clinical research but with a system that’s more agile, transparent, and innovation-friendly.

If you’re running or planning a clinical trial in the UK, now’s the time to review your protocols, governance processes and documentation.

📄 Read the full MHRA/HRA blog here: https://lnkd.in/ebbGeEAz

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