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

Most quality leaders in medical device companies struggle with recurring NCs, failing CAPAs, and constant overload.

Findings on NC & CAPA systems dominate every year (483s, Warning Letters, and Notified Bodies reports).

Processes are too complex, timelines drag, and ownership sits only with QA.

Each review reveals that CAPAs are opened for minor issues or lack clarity about what issue is solved. On top:

1. Investigations miss root causes, and effectiveness fails
2. Records are neglected, and actions are overdue
3. Metrics are red, and leadership is frustrated

This means you as the person responsible for quality get all the pressure.

Imagine a CAPA system that actually works. 

One that spots issues early, runs smoothly, and earns confidence from auditors and leadership alike.

I help quality managers, directors, and VPs redesign their NC&CAPA systems:

- simplifying processes,
- strengthening root cause analysis, and
- building effective governance.

I focus on practical fixes that fit your reality, not theoretical frameworks.

Let’s make your CAPA system your strongest asset ... not your biggest headache.

Things I do with my clients:

- Train their organization so investigations identify root causes, not symptoms
- Simplify procedures so CAPAs are initiated for high-risk issues, not minor problems
- Analyze process health and propose a realistic improvement plan (+ help you with implementation)

Some results (check below for more):

- Created dashboards that manage 500+ open records and visualize each status and risk in seconds
- Trained 400+ people on NC/CAPA execution that led to stopping 'human error' as the root cause
- Redesigned procedures to stop opening CAPA for trivial, no-risk matters (reduced # of CAPA by 30%)

If you're a quality leader in the medical devices industry (ISO 13485) looking to remove complexity from your processes, book a call with me or send me a message.

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