Medical Device Certification: Bureau Veritas Switzerland leverages on the ISM District to offer full range services

We were notified under the MDR in August 2022 and today we can boast an organization and expertise that covers the sector internationally.
Aware of the market potential and the complexity of the sector, we have strengthened the team both with internal personnel (+30% since 2022) and with external professionals, recording an overall growth of resources of 40% in the last 2 years.
We have structured our team to ensure widespread presence thanks to an important sales network, key figures in the management of the process - from application review, to back office, to planning - and in particular, technical personnel - auditors, product reviewers, clinicians and technical and clinical experts.

All these resources play a fundamental role, with the aim of offering an effective and efficient service, in compliance with regulatory requirements.
To address the specificities of the highly regulated sector, our team - both technical and support - are dedicated annual targeted training programs, to respond to updates both at the regulatory and technical level.

As the Bureau Veritas International Competence Centre for medical devices, our commitment extends beyond national borders, dialoguing with local offices and qualified auditors.

In particular, in 2025 Bureau Veritas consolidated its activities in Switzerland through its Zurich office by focusing on resources and expertise, ensuring a local presence in Switzerland of qualified personnel dedicated to Swiss manufacturers and ensuring availability and delivery with reliable deadlines at all stages, from pre to post-certification. Our local presence, combined with global expertise, puts us in the best position to support your certification needs efficiently and effectively.

In addition to CE marking for medical devices, the team also deals with ISO 13485 certification, the reference standard for the quality management system of medical devices.

As an accredited certification Body, we conduct independent Third-party audits to assess Management Systems and provide certification services in accordance with the ISO 13485 Standard.
Just recently, we have obtained the extension of our accreditation to the technical area related to hydrogen peroxide sterilization, which represents a distinctive element for us.

There are also important technical developments, such as the impact of artificial intelligence in the healthcare sector and in particular in the medical field, with the involvement of software medical devices. Moreover, the scope of MDR notification covers a wide range of medical devices that require specific vertical preparation, alongside transversal competencies.

For example, I think of medical devices based on substances, a peculiar sector, characterized by a complex and still debated technical-regulatory landscape, and which, together with software medical devices and artificial intelligence, represent the current challenge.