Medical Devices Quality System

Synergy Bioscience is a leader in the medical device consulting industry, focused on delivering strategic regulatory planning and support, FDA and international regulatory submissions, and unmatched quality assurance and compliance services to address FDA QSR and ISO 13485. We understand that Quality Systems and practices are paramount in Medical Device Development. That’s why all the work we do adheres to stringent regulatory requirements and guidelines. We tailor our Medical Device Consulting to your product needs by providing the right solution based on an in-depth understanding of the challenges and opportunities your product creates. Whether you need help with submissions, responding to Regulatory Authorities regarding regulatory compliance, or help with a multi-country strategy, Synergy Bioscience  has the exact expertise you need for medical device development and commercialization success.



  • Quality Systems Development & Review (QSR, ISO 13485, .. etc)
  • Full life cycle approach to medical device development
  • Premarket FDA clearance and approval strategies, submissions, appeals, and panel meeting preparation.
  • Post market product surveillance and stewardship activities.
  • 510(k), PMA, IDE, CE-marking for Class I, II and III devices and other international categories resulting in successful submissions
  • Perform independent verification/validation of medical systems to support your submissions
  • Risk assessment & hazard analysis consulting
  • Process validation – Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)
  • Part 11 & HIPAA Compliance review
  • Software quality assurance; verification and validation
  • Training of your employees in FDA or ISO approved Medical Device Standards
  • FDA, ISO, CE and other international medical device safety consulting
  • Design documentation services
  • cGMP and QSR compliance audits and support to corrective actions.
  • Litigation support and expert testimony.
  • Regulatory Classifications, Applications and Submissions
  • Notified Body Choice and Liaison
  • Innovative, cost effective, Clinical Trial Design and Management
  • Language & Labeling
  • Usability and Human Factors clinical protocol design and execution
  • Strategic Compliance and Risk Management
  • Independent Third-Party & Due Diligence Audits
  • Validation Solutions
  • Inspection Readiness Preparedness and Training
  • Product, Process and Business Risk Management
  • Integrated Product Stewardship



  • Analyze the benefits / risks for informed decision-making
  • Interpret the regulatory precedents and new legislation
  • Develop the business and regulatory approach
  • Conduct persuasive communication with authorities
  • Execute an effective path to approval
  • Effectively coordinate development in multiple markets
  • Select and qualify appropriate testing and manufacturing vendors
  • Establish a compliant Design Control System incorporating product development and R&D quality assurance
  • Ensure overall compliance with QSR and EU regulations
  • Properly employ international standards



  • Broad insight into your development program
  • Expertise fusing science / technology, regulatory and business
  • Access to a global network of top level consultants
  • In-depth global marketplace knowledge and experience
  • Complete product lifecycle suite of integrated services


Through independent design verification for your medical device development, we’ll make sure it’s right, right from the start. Our independent design verification services provide an independent review of your device to support your FDA/CE Marking or other international submission. This is especially vital for organizations that may only have a limited number of personnel and are not able to provide the necessary level of independent review.


Our services Include

  • Code and Requirements review
  • Verification plan generation
  • Verification protocol generation
  • Safety testing
  • Unit module testing
  • Protocol execution and reports
  • Automated process testing
  • GMP process validation (IQ/OQ/PQ)
  • Usability and Human Factors Review

If you have already performed an initial proof-of-concept work, we can make your product ready for commercial release and clinical trials. We will document the design, development, verification process for a future FDA/CE Marking or other international submission. We’re flexible. Regardless of where you are in the Medical Device Development Process, QCS can help.

To discuss how Synergy Bioscience can help you, please contact us