Karan Dhamija
Founder & Principal Consultant · Manchester, UK
15+ years in QA, RA and Notified Body audit across EU MDR, IVDR, ISO 13485 and FDA 21 CFR 820. Background includes Lead Auditor roles at BSI, senior positions at Johnson & Johnson DePuy, QIAGEN, Philips Healthcare, STRATEC and Randox, covering Class I–III medical devices, IVDs and SaMD platforms including AI/ML-enabled radiology solutions.
Holds an EU Commission Independent Expert credential (EX2026D1360828) and IRCA-certified ISO 13485 Lead Auditor status. Appointed as PRRC and UKRP for multiple clients across the UK and EU.
Ravikant Sanguri
Post-Market Surveillance Consultant · Canada
Specialist in post-market surveillance, pharmacovigilance and data integrity across medical devices and IVDs. Experience at Wipro and Thermo Fisher Scientific spans PMS system design, vigilance reporting and compliance frameworks — built to hold up under audit, not just satisfy documentation requirements.
Supports international clients on PMS strategy and data integrity aligned to EU MDR, Health Canada and global regulatory expectations.
Ganesh Singh Bisht
QA/RA Consultant · UAE, India & Rest of World Markets
Specialises in quality assurance and regulatory affairs for UAE, India and Rest of World market registrations. Experience at Fresenius, QIAGEN, Align Technology and Alere covers a wide range of device classifications and regulatory jurisdictions — supporting manufacturers where pathways are less standardised and require practitioner-level navigation.
Focus areas include market entry strategy for UAE and India, technical documentation alignment and QMS implementation for non-EU, non-US regulatory submissions.