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Regulatory Services

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The Know-How to Navigate the Path Toward Clearance.

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

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