Our team helps determine your product regulatory position such as:

• product intended use,

• indications for use,

• classification rationale and

• country specific quality system requirements according to the jurisdiction(s) in which marketing authorisation is sought EU, UK, or US.

Our team will help you build the technical file (Medical file, Design History File) structure according to the jurisdiction(s) in which marketing authorisation is sought EU, UK, or US :

• Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) for devices placed on the market in the EU

• UK Medical Devices Regulation of 2002 for devices placed on the market in the United Kingdom

• Chapter 21 of the Code of Federal Regulations for for devices placed on the market in the US market

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Get our help with:​

• Post Market surveillance plan and reports

• Periodic Safety Updates Reports (PSUR)

Get our help with :

Building your own compliant Quality Management system (QMS) based on: ISO13485, 21CFR820, MDSAP.

Get our help with: :

• Regulatory strategy

• Classify your product

• Develop all the Standard Operating Procedures (SOP's) and templates for the agile software development lifecycle so will be fast and efficient

• Work with your product, engineering ,and testing teams to write and build the documentation structure the Product technical file structure according to the jurisdiction(s) in which marketing authorisation is sought EU, UK, or

• Get your MDR 2017/745 Compliant QMS

• Selection of the notified body

• QSub or Breakthrough Devices process for FDA approval

• Submission of the Product Technical file for the authorisation

• Post Market surveillance plan and reports

• Periodic Safety Updates Reports