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

Josh Craven

Indo  

18 years of recruitment experience, supporting MedTech/HealthTech and SaMD organisations with a core focus on challenging and senior-level hires within Regulatory Affairs, Compliance, Clinical Evidence/Research and Commercialisation. 

Specialist in supporting organisations with SaMD or highly advanced active medical technologies. 

Indo placement record includes; 
Regulatory Affairs / Quality Engineering & Assurance / Clinical Research
Compliance & Risk
Clinical & Medical Affairs – including CMO & Medical Director 
Commercial – including Sales/Marketing/Market Access
Leadership – including C-Suite & Director level 
Change & Transformation
Operations – including Finance/Operations

Recruitment For MedTech & HealthTech 

Clinical Professionals

I established the new MedTech Division focused on the supply of contract and permanent professionals within Regulatory Affairs, Quality Assurance and Clinical Research. 

Specialising in supporting Start-up, SME and Global Medical Technology staffing requirements securing multiple Director / Head & VP level hires. 

Previously held positions included Business Manager, Senior & Principle Consultant - contract & permanent divisions. 

Developed multiple Client/PSL relationships with an excellent track record of repeat business in skills short professions.

Mentor and multiple company award winner within consultant and team leadership roles.

Recruitment Manager - MedTech Recruitment 

Holden Jones

Recruitment Consultant - Accountancy & Finance

Senior Recruitment Consultant

The Emerald Group

Recruitment Consultant - Risk & Compliance within Insurance / Investment Management

Recruitment Consultant - Risk & Compliance

Project Resource Ltd

Recruitment Consultant - Commercial Team (Cost Managers / Quantity Surveyors)

Recruitment Consultant

🌟 Expert Recruiter in MedTech and HealthTech | Co-Founder of Indo Search 🌟

With 18 years of recruitment experience and a decade specialising in MedTech and HealthTech, I focus on placing hires up to senior leadership across regulatory, quality, clinical research, sales, and marketing.

At Indo Search, co-founded with Ridda Michail in 2019, we offer tailored recruitment solutions including:

🗺️ Talent Mapping and Real-Time Market Analysis
🔍 Proactive Searches
📈 Visually Enhanced Digital Job Introductions

Our digital introductions effectively showcase clients’ culture, patient impact, products, team dynamics, values, and leadership. This approach highlights our clients' broader employer branding and value proposition (EVP), attracting like-minded professionals who fit well culturally and stay longer, delivering clear ROI:

📊 90% Retention Rate for the first two years
✅ 100% Placement Record on all search assignments

A key strength is our creation of immersive digital job descriptions that stand out in a competitive market and boost candidate engagement.

🚀 Success Story: Filling Critical Positions & Launching a Cutting-Edge Product 🚀

We supported a rapidly expanding MedTech scale-up based in Cambridge with significant investments, needing to fill 14 critical roles urgently to meet their ambitious deadlines for a product launch.

Our expertise helped them fill key positions including:

🩺 Head of Clinical/Medical Director
✔️ Head of Quality
📋 Multiple Regulatory Affairs Managers & Specialists (pre & post market)
💼 Sales Director
🌍 Government Affairs Advisor
📊 Senior Marketing Manager
📈 Multiple Sales and Marketing Hires

Our work resulted in a 100% acceptance rate for job offers and provided valuable strategic input on clinical research, regulatory approval, and global sales and marketing efforts, ensuring their product launch was successful and their investment maximised.

Co-Founder / Director - MedTech & HealthTech Recruitment

10 years of experience recruiting in MedTech with a core focus on Regulatory, Compliance and Clinical Research hires up to Medical Director / CMO. 

Specialist in supporting organisations with SaMD or highly advanced active medical technologies. 

Supporting Start-Up, Scale-Up, SME and Global organisations in MedTech, HealthTech. 

Indo placement record includes; 
Regulatory Affairs / Quality Engineering & Assurance / Clinical Research
Compliance & Risk
Clinical & Medical Affairs – including CMO & Medical Director 
Commercial – including Sales/Marketing/Market Access
Leadership – including C-Suite & Director level 
Change & Transformation
Operations – including Finance/Operations

taplio

The Battle

Karandeep Badwal

Josh Craven

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