Regulatory Affairs

Development, manufacturing and marketing of medical devices is a highly regulated process with strict governmental requirements.

SP Medical provides strategic planning and performance of regulatory activities in compliance with medical devices regulations within EU, Asia and US. This is achieved through a team approached relationship with our customers.

By using our experience in screening and evaluating new ideas, and offering you to be be an active partner of your R&D projects, we can offer you a proactive provision of advice, on-going guidance, as well as an administrative quality check of your regulatory documents.

Furthermore, we are able to develop and implement regulatory strategies for the existing product registrations, including annual reviews and plans for the current portfolio.

Our RA support subsists of, but not limited to:

  • Preparation, submission and approval of CE-mark applications covering medical devices class I, II and III, hereby establishment and maintenance of device Technical File and/or Design Dossier
  • Evaluates the regulatory impact on Technical File/Design Dossier with respect  to product changes, and perform complete regulatory assessment of the existing documentation
  • Provides direct regulatory support to project teams including creation of Design Control File, Risk Management File and elaboration of detailed regulatory plans


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    Medical device regulatory requirements require the appropriate diligence before a medical device can receive regulatory approval and go to market.


    We have the expertise to help your medical device meet the many challenges of medical device regulations during the approval process.

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