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Quality & Regulatory Services


Ensure Your Quality System is an Efficient Pathway to Commercial Success.

Developing a compliant, yet not overly complex, Quality System can be a challenging and ongoing effort that encompasses the entire product development process and affects how your business operates. Partnering with Orchid Design’s quality experts can help with simplifying your existing system, or developing a new system with and an efficient methodology customized around your specific business needs.

And to help ensure your continued compliance to ISO 13485, FDA QSR, and/or MDD requirements, we can provide on-site training and auditing activities.

Quality Systems Services

  • Development of customized Quality Systems
  • Implementation and adoption into practice
  • Authoring and technical writing of procedures and manual
  • Training of personnel - including ISO 13485, FDA QSR (GMPs), Corrective Actions
  • Auditing - including Internal, Supplier, Due Diligence
  • Continuous Improvement/Gap Assessments - including ISO 13485, FDA QSR (GMPs), Europe MDD
  • Mock FDA inspections
  • Risk management

Developing appropriate device submissions requires considering the regulatory path at the start of the design and throughout the entire development process.

Working in accordance with FDA and MDD guidelines, Orchid Design’s regulatory team can provide the knowledge, preparation and process needed to develop appropriate submission strategies that ensure compliance throughout the development process to maximize the opportunity for regulatory clearance success.

Acting as your official correspondent to the regulatory agencies, we can develop the appropriate strategy, prepare the required documentation and submit the completed package for clearance review.

Regulatory Services

  • Submission strategy development
  • Device classification and predicate selection
  • Comparative testing identification
  • 510(k) pre-market notifications
  • PMA submissions
  • CE mark/technical files and design dossiers
  • Canadian medical device licensing
  • FDA establishment registration and device listing
  • U.S. agent for foreign medical device manufacturers
  • Adverse event reporting
  • Recall guidance
  • 483 and Warning Letter response support