Keystone Regulatory Services, LLC
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 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.