Karandeep Singh Badwal
Medical Devices Tutor @Bywater
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WORK HISTORY
Medical Devices Tutor @Bywater
Certified Tutor for EU MDR, IVDR, ISO 14971, Risk Analysis, MDSAP & Medical Devices
EDUCATION
De Montfort University
BSc (Hons) Pharmaceutical and Cosmetic Science
De Montfort University
MSc Pharmaceutical Quality by Design
The Open University
Molecules, Medicines and Drugs
SKILLS
ABOUT KARANDEEP SINGH BADWAL
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
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