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

Could you handle the pressure of an FDA inspection tomorrow?  

What if your QMS wasn’t ready, leaving you exposed to costly delays or penalties?  

For many MedTech companies, audits feel like a disaster waiting to happen. Missed compliance issues can lead to expensive 483s, warning letters, or worse: halted operations.  

Here’s how I help:

With over a decade of experience in internal audits for medical device, pharmaceutical, and combination product manufacturers, I simplify the audit process and help you avoid costly mistakes. My approach combines AI-driven insights with human expertise, so you get precise, actionable solutions tailored to your unique challenges.  

You’ll know exactly what’s working, what isn’t, and how to fix it, giving you peace of mind before the FDA or a notified body ever steps in.  

I’ve led dozens of internal audits across key standards and regulations:  
→ ISO 13485  
→ QSR  
→ EU MDR  
→ MDSAP  
→ ISO 14971  
→ QMSR  

If there’s a compliance framework in MedTech, chances are I’ve worked with it. My clients rely on me to prepare them for smooth FDA inspections and notified body audits by addressing issues early... before they become costly problems.  

Here's what one of my clients said:
"Darrin’s meticulous approach and deep expertise identified critical areas for improvement and gave us actionable recommendations. Thanks to his intervention, we now have a clearer understanding of our processes and a robust framework for future growth."

Do you need help reducing audit risks and avoiding compliance headaches? 
→ Message me here on LinkedIn and let's chat.  
→ Join 700+ professionals who subscribe to my QA/RA Playbook and get free access to my ISO 13485 Pocket Guide! (Link in Featured section.)

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