Resources – Regulatory & Compliance



Regulatory & Compliance

Chris Bouchee – Medical Engineering Consultants (MEC)

Medical Engineering Consultants (MEC) is a consulting and training firm that provides services that cover design and development, quality management systems (QMS), manufacturing, and regulatory submissions.  These services range from individual contributors to full scoping, staffing and execution of small or large scale projects.  Our founders are industry veterans with over 40 years’ experience in R&D, Operations, Quality and Regulatory roles and truly understand your individual project needs.

Please get in touch to discuss your consulting, contracting or training needs!

  • Design Controls – Design Verification and Validation
  • QMS Implementation, Gap Assessments and Closure
  • Project Management – Custom Tailored to your needs
  • Regulatory Pathways – Submission Type and Strategy
  • Training and Organizational Change Management

View Medical Engineering Consultants Website

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Mark Gardner — Gardner Law, Medico-Legal Experts

Gardner Law, PLLC provides legal and regulatory counsel to the medical technology, pharmaceutical, and biotech industries. Our pragmatic and responsive attorneys have worked in industry—which sets them apart from other lawyers. They provide practical advice to leaders across the world navigating the complex healthcare regulatory environment. Gardner Law provides advice at all stages of the product life cycle from ideation, R&D, clinical testing and regulatory submission, to manufacturing and commercialization.

Practice areas:
• FDA approval pathways, quality and regulatory assessments
• Healthcare compliance assessments
• Design/implementation of compliance programs, investigations, & training
• Advertising and promotion review
• Interactions with healthcare professionals
• Responding to, and negotiating with, regulators and prosecutors
• Sunshine reporting
• Clinical research
• Privacy matters

View Mark’s Website

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Ross Meisner — Basil Systems

We can help you better understand your competitor’s technologies and strengthen your FDA applications to achieve a faster approval. Questions we can help you answer include: Who else is in the market? What quality problems have they had? Which predicates should we use?

Basil Systems modernizes how RA/QA teams and business leaders can accelerate FDA submissions, streamline post-market surveillance, and inform competitive due diligence. By using our SaaS platform, companies, investors, and RA/QA consultants can quickly master these questions and the relevant regulatory landscape in record time. Basil helps you find all related products, visually navigate the 510(k) ecosystem, and plumb the details of PMAs, De Novos, and HDEs with just a few clicks. We make it easy to find product recalls and research adverse event trends and causes. In addition, we serve up related clinical trials and provide time-to-approval statistics to help get your product to market faster.

View Basil System’s Website

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Anne Quinlan-Smith

Is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.

View Anne’s LinkedIn Profile

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