Medical Devices

The increasing complexity of the regulatory environment for medical devices is a clear indication of significant importance of the medical sector. We help manage regulatory and quality requirements and ensure compliance with legal conditions. We find creative and solid solutions, prepare robust documentation and maintain your product according to the current state of knowledge. Take advantage of our expertise, especially for borderline products, and strengthen your competitiveness.

Person Responsible for Regulatory Compliance (PRRC)

According to EU Regulation 2017/745 (Medical Device Regulation, MDR), manufacturers of medical devices must nominate a Person Responsible for Regulatory Compliance (PRRC), who is responsible in particular for regulatory compliance. With the required expertise in the field of medical devices, we take over the responsibilities of a qualified, experienced PRRC for you and take care of post-market surveillance and vigilance obligations.

Preparation of technical documentation

We are happy to manage the creation and maintenance of the technical documentation for your medical device, ensuring that the certification in accordance with MDR is achieved without any hindrance. Our services include:

• Evaluation of existing documentation & gap analysis
• Update & review of technical documentation
• Update & review of PIL & labeling
• Post-marketing surveillance

Conformity assessment procedure

The regulatory path to a CE label can be very demanding. We offer tailored strategies based on the particular risk classification of the product. We are happy to support you with:

• Creation of product classification reviews and reports to ensure your product is classified correctly despite complex classification rules.
• Discussion with notified bodies on product classification.
• Conformity assessment consulting & CE certification documentation.

Vigilance for medical devices

An adequate vigilance system at medical device manufacturers is necessary to ensure medical device surveillance and product safety in accordance with EU Regulation 2017/745. Here you can benefit from our expertise in:

• Incident management
• Implementation of trend messages
• Recall handling
• Creation of PMS reports or PSUR

Implementation of QMS

According to EU Regulation 2017/745, medical device manufacturers need a suitable QMS. We help you with the definition, implementation and everything that goes with it:

• Implementation of the QM system (ISO 13485)
• Creation, review & update of SOPs and other necessary quality documents
• Creation, review & implementation of training courses
• Internal online and on-site audits or at third parties (suppliers, manufacturers, distributors, etc.)
• Support during audits of the notified body
• Support in the implementation of appropriate deviation/ CAPA management.
• Definition & implementation of action plans related to CAPAs.

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