Complete Regulatory Services for the Medical Device Industry
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Keystone Regulatory Services, LLC

Complete Regulatory Services for the Medical Device Industry

 

Advocating for small and large medical device organizations since 2004

Headquartered in eastern Pennsylvania, Keystone Regulatory Services, LLC works with small and large medical device organizations around the world.  Our firm 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 has over 25 years of experience in the medical device industry and has helped dozens of organizations obtain regulatory clearances, maintain effective Quality Management Systems and resolve regulatory disputes.

Get in touch with us to set up a consultation, or use the contact form at the bottom of this page to enquire whether our services are right for you.

Contact

➤ LOCATION

342 E. Main Street
Suite 207
Leola, PA 17540

☎ CONTACT

bill.mclain@keystoneregulatory.com
(717) 656-9656

 

Areas of Practice - Services Provided


Premarket REGULATORY Strategy and Support

  • Market Entry Strategy
  •  Design Verification and Validation Testing Strategy and Oversight
  • 510(k) / IDE / PMA
  • CE Marking / Technical File / Design Dossier Preparation
  • Combination Products
  • Medical Device Development Project Management
  • Canadian Medical Device Licensing
  • International Product Registrations
  • Clinical Study Development and Guidance (Through referrals to qualified associates)

Risk Management Consulting

  • EN ISO 14971:2012 Transitioning
  • EN ISO 14971:2012 Training
  • Risk Analysis / Risk Management
  • Integrating Risk Management with Quality Systems


Quality Management System Consulting
 

  •  ISO 13485:2016 Implementation and Transitions
  •  ISO 13485:2016 Training
  • MDSAP Implementation
  •  Quality System Gap Analysis
  •  Quality System Development / Optimization
  •  Implementing Quality Management Systems In “Virtual” Companies
  •  cGMP (21 CFR Part 820) Training and Implementation


Postmarket compliance / Dispute resolution

  • MDR/Vigilance Assessment and Reporting Support
  • Advertising and Promotion Review
  • 483, Warning Letter, Untitled Letter Response Strategy
  • Audit Nonconformance Response Strategy

Quality System Auditing
 

  • Supplier Auditing
  • QMS Auditing
  • QMS Gap Analysis
  • Auditor Training to the Process Approach
  • Preparation for FDA Inspection or NB audit
  • MDSAP Mock or Preparatory Audits


Other Services

  • Expert Witness
  • US Agent for Medical Devices
  • Contract Regulatory Officer
  • Acquisition Due Diligence

 
 

 
 
 

Let's Chat.

Use the form below to contact us regarding your RA/QA enquiry.  

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