Keystone Regulatory Services, Llc

Keystone Regulatory Services, LLC specializes in helping your organization place and keep medical devices on the market. We help you communicate your RA/QA story to regulatory agencies, auditors, and inspectors. Our Principal Consultant and Sr. Consultant have over 40 years of combined experience in the medical device industry and have helped dozens of organizations obtain regulatory clearances, implement and maintain effective Quality Management Systems, and resolve regulatory disputes. Services Include: • Premarket Regulatory Strategy and Support (market entry strategy, design verification and validation support, 510(k)/ IDE / PMA prep, EU MDR and EU MDD CE marking support, technical file prep, international product registration, etc.) • Quality Management System Consulting (EU MDR, ISO 13485:2016, MDSAP, and ISO 9001:2015 system implementation and certification support, 21 CFR 820 system implementation and support, QMS gap analysis, QMS training, electronic QMS implemention and transition, etc.) • Quality System Auditing (QMS auditing, supplier auditing, FDA inspection and notified body audit preparation, etc.) • Risk Management Consulting (ISO 14971:2019 transitioning, risk management system implementation, etc.) • Postmarket Compliance / Dispute Resolution (post-market surveillance support, vigilance assessment and reporting support, advertising and promotion review, 483/warning letter/audit nonconformity response strategy, etc.) • Other Services (expert witness, contract regulatory officer, acquisition due diligence, etc.)