Karandeep Badwal
Karandeep Badwal, Director and Lead QARA Consultant, QRA Medical
Karandeep Badwal is the Director and Lead QARA Consultant at QRA Medical, an independent regulatory affairs and quality consultancy working with SME manufacturers, digital health startups and Software as a Medical Device companies across the UK, EU and US.
His work is end-to-end. Quality management systems, regulatory submissions, audits, remediation and strategic advisory. He covers FDA pathways including 510(k), De Novo, AI/ML and PCCP alongside EU MDR, IVDR, UK MDR, SaMD classification, ISO 13485, ISO 14971 and IEC 62304. The real job is helping CEOs and founders understand what they actually need to do, then stripping away everything that does not apply.
One belief runs through all of his work. Regulatory is not as complicated as the industry makes out. The problem is rarely the regulation itself. It is departments that do not talk to each other and compliance that gets bolted on at the end instead of built in from the start. Get the culture right and the rest follows. As he puts it, a QMS is built not bought and quality is a culture not a department.
He is a CQI/IRCA certified ISO 13485 Lead Auditor and EU MDR Practitioner, an Innovate UK assessor and a MedTech Innovator judge. He delivers accredited training and guest lectures on biomedical innovation. He also hosts The MedTech Podcast, now in its fourth year with over 100 episodes, bringing founders, regulators and industry leaders together to talk honestly about what works and what does not.
Before founding QRA Medical, Karandeep held quality and regulatory roles at Abbott and St. Jude Medical and across the wider medical device and pharmaceutical sector. He holds an MSc in Pharmaceutical Quality by Design and a BSc in Pharmaceutical and Cosmetic Science.
Whether he is advising a pre-seed startup or remediating a mature quality system, the approach is the same. Plain language, practical action and no jargon for the sake of it.