Service features

Product technical file

We develop the technical file for CE marking of medical devices and commercial products based on the 2017/745 medical device regulation (MDR), or the machinery, low voltage, and electromagnetic compatibility directives.

Context and introduction

CE marking ensures that safe products can circulate freely within the European Union. Specifically, the manufacturer must develop and maintain an updated technical file on the product to document its compliance with general safety and performance requirements as defined by regulations or guidelines.

01

Medical devices

We develop the technical file for the certification of class I and class I sterile medical devices (electromedical and non-electromedical), including those with measuring functions and those that are reusable, as well as class IIa, IIb and III devices; based on the 2017/745 medical device regulation (MDR) and harmonised standards.

02

Commercial products

We develop the technical file for the certification of commercial products complying with the low voltage (2014/35/EU), electromagnetic compatibility (2014/30/EU), and machinery (2006/42/EC) directives.

03

Detailed documents

We can develop single documents: EN 14971 risk management, MEDDEV 2.7.1 clinical evaluation, EN 60601-1-6 and EN 62366, and EN 62304 software compliance. These can also be used to supplement pre-existing technical files.

04

Change management

We set out the impact of modifications to the product and the process, and the best strategy to manage them. We also adapt the documentation and deal with the approval of the technical file from the notified body.

05

Relationship management

We have the technical experience required to manage relationships with any testing laboratories and notified bodies. We deal with them directly and manage requests for proposals, the planning stages, and launching operations

Contact us

Requirement analysis.

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