Getting your medical device approved shouldn’t take years of trial and error

I help early-stage MedTech founders get a clear EU MDR, UKCA and/or FDA regulatory strategy in just 30 days so they can move forward with confidence, reduce delays and get to market faster

The problem:
Many founders are unsure which pathway applies, what documents are required or how to avoid months of regulatory back-and-forth. Without a clear plan, they risk burning runway, missing opportunities and losing investor confidence

How I help:

- Map the exact regulatory pathway (CE, UKCA, 510(k), De Novo, PMA)
- Define intended use & classification to align with regulators
- Build a step-by-step submission readiness plan
- Provide hands-on support for technical documentation, QMS & audits
- Guide devices including SaMD, AI/ML, hardware and IVDs through IEC 62304, IEC 82304, applicable ISO standards and emerging AI frameworks

Full capabilities:

Regulatory consulting: CE marking under MDR/IVDR, UKCA certification, FDA pathways (510(k), De Novo, PMA). PRRC & UKRP services. Gap assessments, submission support & strategic planning

Quality assurance: Implement & remediate QMS to ISO 13485 & MDSAP. Lead audits, manage CAPAs & complaints, support risk management (ISO 14971), process validation (IQ, OQ, PQ) & sterilisation (ISO 11607). Certified ISO 13485 Lead Auditor (CQI/IRCA)

Digital health / SaMD: Compliance with IEC 62304, IEC 82304 & AI/ML frameworks. Software validation & CSV for regulatory alignment

eQMS platforms: Implement Greenlight Guru, Qualio, MasterControl, JIRA & Confluence, with CSV to ensure audit readiness

Due diligence: Regulatory & QMS assessments for investors, accelerators & M&A. Identify red flags in technical documentation & submissions before they become costly

Training & microconsulting: For teams & founders building internal capability. CQI/IRCA-registered tutor for MDR, IVDR, ISO 13485, ISO 14971 & MDSAP

I’m a startup advisor and competition judge for MedTech Innovator, Springboard Enterprises and MassChallenge. As a trainer and host of The MedTech Podcast, I work with founders, investors and accelerators worldwide to deliver regulatory clarity and practical strategies

I combine regulatory expertise with a practical, execution-focused mindset. Clients value my ability to cut through complexity, reduce time to market, pass audits and scale confidently, whether launching a first product or expanding internationally

If you’re navigating regulatory uncertainty or preparing for growth, let’s connect

🎙️ The MedTech Podcast | 📺 YouTube: @KarandeepBadwal

Karandeep Badwal

My wish is to support the needs of pharmaceutical and medical devices companies to reach their objectives and to help patients to obtain the product they need. 

I've acquired during my career sufficient knowledge to drive projects related to quality and regulatory affairs and had experienced many successes but also some difficulties which helped me to learn more.

To start that journey I created EasyMedicalDevice.com which is here to bring some awareness on all the new regulations transitions that are ongoing.

As you can see by the name of the site, the objective is to make the Medical Device Regulations and Standards easy to understand. 

Read my blog posts and look at my Youtube channel and subscribe to my podcast (Medical Device made Easy) so you can learn how to place a compliant medical device on the market.

My Motto is: "WOULD I GIVE THIS PRODUCT TO A MEMBER OF MY FAMILY?" so don't forget that health is one of the most important pieces of your life. Don't destroy it.

About me:
For my background, I am specialized in Quality and Regulatory Affairs for Medical Devices and also have some experience in Medicinal Products. This helped me to acquire knowledge of combination products and borderline products.

Below are some of the standards and regulations I practiced:
For devices - Medical Device Directive MDR 2017/745, IVDR 2017/746, MDD 93/42/EC, 98/79/EC for IVD, FDA 21CFR 820, ANVISA, JPAL and 510K registration, ISO 13485:2016, ISO 14971.

Related to drug - I follow Drug Directive 2001/83/EC.

Additionally, I drove some Process improvement (Change management, PDCA, CAPA)
Lean manufacturing (SMED (Pit stop), Value Stream Mapping, 5S, 6 sigmas)

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