March 5, 2026
Our Richard Vincins was recently invited to talk on the Solutions AP podcast about the regulatory and clinical challenges small and medium sized companies face when entering the EU market. You can find a link to the podcast here:
https://rss.com/podcasts/solutions-op-clinical-trials-uk/2558413/
Richard joined MD Compliance after a 30 year career working in different medical device and IVD companies for 15+ years and other consultancy firms such as Emergo, Oriel Stat-A-Matrix and NAMSA for 15 years .
Richard's skill set encompasses Regulatory Affairs and Quality Assurance Compliance with extensive experience in the medical device, in vitro diagnostic, and health care industry. Experiences include compiling regulatory submissions, regulatory strategy for new and novel products, performing quality system assessments, and supporting audits/inspections of quality systems. Manages teams of individuals, mentoring and coaching on regulatory requirements, training on regulatory topics, and supporting compliance with regulations. Specialized in global Quality Systems Regulations with expertise in submission content, regulatory classifications, risk management, software-driven products, post-market surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.
FDA expert - author of over thirty successful 510(k) submissions and managed over one hundred Q-submission meetings.
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