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Current company Maven Profcon Services LLP
Business Consulting and Services · 93 employees · Founded 2016 · Ahmedabad, Gujarat, India
Maven Profcon Services LLP is a regulatory consulting firm specializing in global medical device and IVD compliance. We help manufacturers navigate complex regulatory frameworks and successfully bring their products to international markets.
Our team works closely with medical device companies across the entire regulatory lifecycle—from documentation, risk management, and clinical evaluation to regulatory approvals and post‑market compliance. Maven combines deep regulatory expertise with a practical understanding of industry requirements to simplify complex compliance pathways.
Our areas of expertise include EU MDR and CE Marking, US FDA 510(k), UKCA certification, ISO 13485 quality management systems, MDSAP, and global market entry strategies for medical device and IVD manufacturers. We also support organizations with regulatory documentation such as Clinical Evaluation Reports (CER), Risk Management Files (RMF), Post‑Market Surveillance (PMS), PSUR, and PMCF activities.
Over the years, Maven has partnered with more than 300 organizations worldwide and has supported a significant proportion of orthopedic implant manufacturers in India in achieving regulatory compliance and international market access.
With a growing team of regulatory experts and consultants, Maven is committed to helping organizations build strong compliance foundations while ensuring that safe and effective medical devices reach global markets.