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

Medical Device / Regulatory Affairs Manager | Entrepreneur | Founder | Notified Body Auditor | Certified Consultant | 2017/745 MDR | ISO 13485 | ISO 14971 | I Help MedTech Companies To Significantly Reduce Time-To-Market

I’m Tibor Zechmeister. For the last 15 years I’ve worked at the crossroads of builder, auditor, and community leader in MedTech.

I started my first medical device company in 2011 with a stubborn question: could we measure what neurologists see? We designed, certified, and launched devices to quantify neurodegenerative disease (tremor and bradykinesia). That founder decade taught me everything the hard way: clinical evaluation, risk management, usability, technical documentation, and the reality of MDR and IVDR transitions when you are racing cash burn. I wrote about those lessons along the way because sharing patterns helps the next team move faster and safer.

Wearing the Notified Body Lead Auditor hat later sharpened my view from the other side of the table. I have seen what truly raises patient safety and what only raises paperwork. I also bring people together in Austria’s regulatory community so that RA/QA experts can trade what works and learn from each other. The RAPS Austria LNG is the melting pot for these activities.

At Flinn.ai, I channel that builder and auditor perspective into AI-enabled regulatory automation. My north star has not changed since 2011: fewer loops, clearer evidence, safer products. I think of it as RegOps, turning regulatory into an operating system teams can actually run. That means technical documentation and traceability that stay current, PMS and PMCF and vigilance that are data-driven, SaMD under IEC 62304 linked to ISO 13485 and ISO 14971 risk, and clean pathways through UDI and EUDAMED. AI is not the point; auditability is.

A few principles I will not compromise on:

- Safety before speed. If a faster path risks patient safety, it is the wrong path.
- Transparency. If you cannot explain your decision trail, you don't have one.
- Ethics. We are talking about patients' lives.
- Innovation with accountability. High-tech plus human expertise, within risk-based, outcome-driven regulation.

What keeps me curious: building software that helps manufacturers prove what they already do well; making PMS and regulatory intelligence useful instead of reactive.

If you are building in MedTech, whether devices, SaMD, or IVD, and care about evidence, speed, and safety, I am always up for exchanging notes. 

I post about MDR and IVDR, SaMD and IEC 62304, ISO 13485 and ISO 14971, PMS and PMCF, EUDAMED, regulatory automation, and the EU AI Act in MedTech. 

Let's connect and have a chat.

When I step away from MedTech it’s usually for a cycling tour, strength training, and a small experiment in evidence-based self-improvement.

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