Keystone Regulatory Services, LLC

Keystone Regulatory Services offers a broad range of consulting services for the medical device industry.  Follow the links below for more information regarding our practical approach to your regulatory affairs and quality system needs.

Consulting Service List
Text Box: ISO 13485:2003 Transition ISO 13485:2003 Training Quality Management System Gap Analysis Quality Management System Development / Optimization Implementing Quality Management Systems in “Virtual” Companies (Companies relying heavily on outsourcing services.) cGMP (21 CFR Part 820) Text Box: Quality Management System Consulting Text Box: ISO 14971:2000 Transitioning ISO 14971:2000 Training Risk Analysis / Risk Management Integrating Risk Management with Quality Systems Text Box: Risk Management Consulting Text Box: Supplier Auditing QMS Auditing QS Gap Analysis Auditor Training to the Process Approach Text Box: Quality Management System Auditing Text Box: Market Entry Strategy Design Verification and Validation Testing Input and Oversight 510(k) / IDE / PMA CE Marking / Technical File / Design Dossier Preparation Combination Products Medical Device Development Project Management Clinical Studies CMD CAS Registration International Product Registrations Text Box: Premarket Regulatory Strategy and Support Text Box: MDR Support Advertising and Promotion Text Box: Postmarket Compliance Text Box: 483, Warning Letter, Untitled Letter Response Strategy Audit Nonconformance Response Strategy Text Box: Dispute Resolution Text Box: Expert Witness US Agent for Medical Devices Contract Regulatory Officer Acquisition Due Diligence Text Box: Other Services

Phone:     717-656-9656

Fax:         717-656-3434

E-mail:     bill.mclain@keystoneregulatory.com

To contact us:

342 E. Main St.

Suite 211

Leola, PA 17540