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

Heading up the UK MedTech / HealthTech Division of Hays.

* Medical Technology - Surgical Robotics through to Diagnostic Devices
* Digital Health - HealthTech, AI Platforms (including AIaMD), SaaS and Software as Medical Device (SaMD)
* Diagnostics 

Our expertise spans key functions:
- Commercial: Sales/Business Development, Marketing, Customer Success/Account Management and Market Access
- Quality, Regulatory, and Clinical
- Product Management & Development
- Digital & Data Leadership: AI/ML, Bioinformatics, Digital Health
- Engineering & Technology: Biomedical, Medical Devices
- Operations Excellence: Manufacturing, Supply Chain, and Engineering
- Research & Analytics: Biostatistics, Data Science, and Advanced Analytics
- Strategic Projects: Change Management, Transformation, and Implementation

We provide comprehensive talent solutions through:
* Retained Search
* Permanent Recruitment
* Interim Leadership
* Project-Based Resources
* MSP

Our proven track record includes transformational partnerships with:
* A pioneering surgical robotics company: Successfully placed 17 key roles during a critical growth phase and product launch, enabling seamless scaling.
* An AI-powered SaMD innovator: Established a retained partnership with a 100% fill rate across strategic hires, accelerating their market entry.
* A global leader in vascular solutions: Executed a sensitive leadership transition through targeted executive search, ensuring continuity and growth.

With deep sector expertise and innovative talent engagement strategies, we consistently achieve a 90%+ permanent placement fill rate, delivering results that matter.

Core sectors:
Medical Technology: Surgical Robotics, Diagnostic Devices, and Beyond
Digital Health: HealthTech, AI Platforms (including AIaMD), SaaS, and Software as Medical Device (SaMD)

Let’s connect if you’re:
- A leader building high-performing teams
- A professional exploring opportunities in MedTech, HealthTech or Digital Health
- An organisation seeking strategic talent solutions to drive growth and innovation

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