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 team has over 40 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
➤ Headquarters
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
FDA 510(k) / IDE / PMA
EU MDD and EU MDR CE Marking Support
Technical File / Design Dossier Preparation
Design Verification and Validation Testing Strategy and Oversight
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
ISO 14971 System Implementation and Training
Risk Analysis / Risk Management
Integrating Risk Management with Quality Systems
Quality Management System Consulting
EU MDR (2017/745) Implementation, Transitions, and Training
ISO 13485:2016 Implementation, Transitions, and Training
ISO 9001:2015 Implementation and Training
Electronic QMS Implementation and Transition Support
MDSAP Implementation
Quality System Gap Analysis
Quality System Development / Optimization
Implementing QMSs In “Virtual” Companies
cGMP (21 CFR Part 820) Training and Implementation
Postmarket compliance / Dispute resolution
FDA MDR/EU Vigilance Assessment and Reporting Support
Post-Market Surveillance Support
Advertising and Promotion Review
FDA 483 / Warning Letter / Untitled Letter Response Strategy
Audit Nonconformance Response Strategy
Quality System Auditing
Supplier Auditing
QMS Internal 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
Product Experience
We have developed Quality Management Systems and/or provided premarket regulatory strategy for the following device types:
Implantable Medical Devices
Extremity Implants - plates, screws, foot, toe, and ankle fixation, wrist and elbow, etc.
Bariatric Implants - markers and satiation devices
Urology Implants
Active Devices
Electrosurgical Instruments
Ultrasound Platforms
Electrostimulation Device
Cardiovascular Devices
Vascular Access Catheters
Intra-Aortic Balloon Catheters
Vascular Closure Devices
Reusable Surgical Instruments
General
Urological
Cardiothoracic
Dental Devices
Temporary Crown and Bridge Resins
Anti-bruxing Devices
Anti-Snoring Devices
Dental Desinsitizers
Sleep Apnea Devices and Components
Software as a Medical Device (SaMD)
AI-based Image Analysis Software
Image Viewing Software
Let's Chat.
Use the form below to contact us regarding your RA/QA enquiry.