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

RRxCo.™

Global Partner for Life. Not just your average Consultancy. 

We are a solution provider that supports the Life Science industry. Joining the best industry experts and recruiters in the industry we can provide the traditional consultancies promise 👉 bespoke, competitive and great value services.

+44 (0) 1256 961200
www.rrxco.com

🔹𝗖𝗢𝗡𝗦𝗨𝗟𝗧𝗔𝗡𝗖𝗬🔹
- QMS Implementation & Development, Quality Harmonisation & Training (GxP & ISO), GAP Analysis
- Mock & Pre-Approval Inspection, Remediation, Risk Management & Assessment
- Submissions & Applications (IND, NDA, ODD, BLA, UCKA, CE, FDA), Regulatory CMC 
- Authority Meetings (MHRA, EMA, FDA), Pathway Development & Reviews
- Clinical Development, Clinical Programme & Project Management
- Clinical Operations (Site Management, Feasibility & Study Start-Up)

🔹𝗔𝗨𝗗𝗜𝗧𝗜𝗡𝗚🔹
- Drug Product/Drug Substance / Medical Device / Dx Devices
- Excipients/Raw Materials & Consumables
- Contract Research Organisations & Clinical Investigator Sites
- Trial Master Files (TMF) & Good Clinical Laboratory Practice (GCLP)
- Nonclinical Laboratories and Pre-Clinical Services
- Warehouse/Distribution Centres
- CSV, Data Integrity & Ancillary Services (Software, Pest Control, etc.)

🔹𝗧𝗘𝗖𝗛𝗡𝗜𝗖𝗔𝗟 𝗧𝗥𝗔𝗜𝗡𝗜𝗡𝗚🔹 
- Quality (CAPA, Change Control, Investigations & Root-Cause Analysis)
- Sterile/Aseptic SME Training
- Regulatory (CMC, Strategy, Operations, Clinical)
- Good Practices & Efficiencies (GxP & ISO)
- Auditing, Risk Management & Assessment

🔹𝗦𝗘𝗔𝗥𝗖𝗛 & 𝗦𝗘𝗟𝗘𝗖𝗧𝗜𝗢𝗡🔹 
- Quality Assurance (GxP) & Quality Control (Chem, Micro, BioChem)
- Process Development (USP, DSP & Analytical) & CMC
- Regulatory (Strategy & Operations)
- Clinical (Clinical Operations & Product Development)
- Operations (Site, Regional & Global Leadership)
- Validation & Data Integrity (Process, Equipment, Cleaning & CSV)
- Project Management (Technical & PMO)

Business Manager - MedTech / Pharma / Biotech

Apotech Consulting

A Business Manager at Apotech Consulting, a specialist Management Consultancy (CSO) delivering end-to-end managed services to the MedTech, Diagnostic (IVD), Pharmaceutical and Biotech industries.

As a trusted global partner and proven life-science specialist, Apotech prides itself on delivering flexible, bespoke solutions tailored to meet the varying needs of its clients.

Working out of the London HQ and Paris

Our services include:
- EU MDR & IVDR Technical Documentation Authoring 
- UK Responsible Person (UKRP)
- FDA Regulatory submissions; 510(k), De Novo, PMA
- CER, PER & PMCF Authoring
- Regulatory Strategy
- ISO 13485 QMS development and maintenance
- Clinical Operational support and strategy
- Local Agent Support for market expansion

Business Manager - Medical Devices 

Life Science People

Working closely with a number of Medical Device Manufacturers, IVD Organisations and Consultancies throughout the UK, EMA and US (East Coast).

Specialities: ISO 13485, Audit, CE Marking, 510(k), Regulatory Affairs, RA, PMA, IDE, FDA, MDD, IVDD, MDR, IVDR, CAPA, ISO14971, Risk Management, Class I, Class IIa, Class IIb, Class III, Medical Devices, Medical Device Directive, Regulatory Affairs, Regulatory Affairs Expert, Regulatory Affairs Specialist, Medical Device Director, ISO 14155, CFR 21, PART 11, FDA, Regulatory Affairs Manager and Regulatory Affairs Associates. 

Our mission at Life Science People is to make a tangible contribution to global health.

We use our expertise to map and secure the highest calibre of talent. Matching them with thought-leading companies which are facilitating global medical advances.

We take a collaborative approach when patterning with these organisations across their entire project life cycle, be that drug, device or data platform.

We provide a number of bespoke solutions, including scalable embedded recruitment solutions, retained and contingent permanent placements and contractor recruitment and management.

Senior Consultant

Skills Alliance

Skills Alliance is a leading Global Life Sciences executive staffing partner. Providing bespoke solutions for the life sciences and medical technology market for over a decade.

• Skills Alliance offer a full portfolio of bespoke solutions tailored to our client’s requirements. These services range from C-suite Executive Search through to Contract/Interim solutions, Benchmarking and an RPO offering.

• Skills Alliance has a growing presence in the global Pharmaceutical market having placed candidates across 20+ Countries with skill sets ranging from pre-clinical through to post-approval.

• Skills Alliance currently has 100+ pharmaceutical professionals working at sponsor sites or via CROs in the UK and a rapidly growing contract base across mainland Europe.

• Office locations across Europe and North America are allowing for rapid growth with a continued focus on our key values that are based around the quality of delivery and client support.

BUSINESS UNITS:
• R&D - Clinical, Regulatory, Medical, QA, HEOR, Commercial, Biometrics, PVG

• Professional Services - IT, A&F, Procurement & Supply Chain, HR & Manufacturing

SERVICE LINES:
• Executive Search
• Database/Advertised Search
• Contract recruitment
• Interim management
• Recruitment Process Outsourcing
• Benchmarking Services

In my current role, I research, identify and establish new business opportunities through strategic planning and entrepreneurial application, working in a 360 capacity.

Recruitment Consultant

Antelope

Business Analyst

A Business Manager at RRxCo, with a background in the Medical Device and IVD space. A strong expertise in generation of business portfolios within MedTech, and project delivery.

Our MedTech services include:
- EU MDR & IVDR Technical Documentation Authoring 
- FDA Regulatory submissions; 510(k), De Novo, PMA
- CER, PER & PMCF Authoring
- Regulatory Strategy
- ISO 13485 QMS development and maintenance
- Audits 

Contact Details:
Email: jack@rrxco.com
Phone: +447788260835

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