Vineeshkumar P V

Medical Device R&D and Regulatory Consultant with 10+ years of experience driving product development and ensuring regulatory compliance. I provide freelance services encompassing the entire product lifecycle, from concept to market, specializing in US FDA submissions (510(k)), design control, risk management, and quality management systems (ISO 13485). My expertise helps clients navigate complex challenges, accelerate product development, and achieve regulatory approval efficiently.

Results-driven Engineering Lead with extensive experience managing medical device R&D projects across the complete product lifecycle and navigating US FDA regulatory pathways. Offers expertise in:

• Product Development: From initial concept and design, including benchmarking and reverse engineering, through to realization, enhancement, and sustenance.
• Regulatory Affairs: US FDA 510(k) submissions, design control (21 CFR 820), risk management (ISO 14971), regulatory strategy development, Q-submission discussions, and due diligence.
• Quality Management: Med-QMS implementation (ISO 13485) and auditing to ensure compliance with regulatory standards (US FDA and Indian MDR 2017).
• Engineering Skills: System engineering, design thinking, innovation, change management, and cost-saving project execution.

Mechanical Engineering