Product accreditation in accordance with the Medical Devices Act is of increasing importance for the commercial implementation of new technologies in medicine. Due to the long preliminary process of development and product accreditation, along with increasingly short product lifecycles, a fast entry into the market is a decisive factor.

EXCO is an experienced partner who will take the preparation of product accreditation into account during the evaluation phase of your products by means of documentation that conforms with the Medical Devices Act. This can significantly accelerate product accreditation and result in the CE Label being granted.

EXCO specialises in product accreditation documentation for the filing of applications with notified bodies in Europe (IVD Directive, CE Label) and the USA (FDA 510 k).

The registration of new and modified medical devices is a complex procedure. The observation of regulatory processes and the creation of the required records, in particular, takes up a lot of time and ties up development capacity.

The support we offer: We can remove the burden from your shoulders by providing professional support with product registration tasks and the creation of documentation for the following sub-tasks:

Documentation creation

• Creation of records for notified bodies (e.g. FDA or IVD)
• Creation of software development and design documentation with
  • Descriptions of intended use of medical device
  • Definition of acceptance criteria
  • Test, development, and design documentation
  • Information processing
• Realization/moderation of risk analyses
• Realization and analysis of human factor studies and user studies for prototypes

Checks of existing documentation

• Review of user requirements
• Review of software specifications
• Review of technical design documentation
• Source code reviews

Product testing and approval

• Creation of traceability records
• Development of a test strategy
• Test design and realization Identification and technical approval of prototypes

Your benefits

• Accelerated registration of new or modified medical devices
• Records for notified bodies (FDA and IVD)
• Regulatory compliance with observance of internal standards and processes
• Quality assurance of documents (e.g. using audits)