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Helping your medical devices achieve long-term success

News from the world of medical devices

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EU – implementing regulation for EUDAMED database published

The EU Commission has published an implementing regulation relating to the EUDAMED database. This governs general questions, e.g. relating to access and registration.

The MDCG has published two additional guidelines in the form of MDCG 2021-25 and MDCG 2021-26, which address the implementation of the MDR for "legacy devices", specifically questions relating to outer packaging/labelling in accordance with Article 16 of the MDR.

The EU Commission has published a proposal for the step-by-step implementation of the in-vitro diagnostics directive, which enables manufacturers to place products in line with the previous directive on the market for longer. Find the press release here.

EU: Additional EUDAMED modules approved

After the module for registration of actors, the EU now also offers the modules for UDI/product registration and notified bodies/certificates, initially for voluntary use. Actors must log in to access these modules; other users can use them without logging in.

EU: New/updated MDCG guidelines published

The MDCG has updated guideline 2019-6 to version 3, which includes questions and answers relating to requirements for notified bodies. MDCG 2021-24 has also been added, containing information about the classification of medical devices.

Medical device manufacturers

A fresh perspective can pave the way for amazing forces of change. We will work hand-in-hand with your team, bringing our expertise, enthusiasm and up-to-date knowledge to your business. Are you experiencing resource bottlenecks in your projects?
We can support you, for instance, in the further development of your QM system, during audits or when creating a technical documentation.

Start-ups

Have you set up your own business with a product idea? Are you on fire for your innovation - but unsure how to meet all the legal and regulatory requirements? Thanks to many years of experience in the medical device industry, we know exactly what is important now. Take advantage of our expertise surrounding development and manufacturing. So that you can concentrate fully on your core competence.

Research facilities

We support research groups in the life sciences sector, helping them to get their research results out into the world – for instance, when developing innovative materials, coatings or new diagnostic methods. When doing so, we always keep the regulatory requirements in mind, which ensures that your research results are always usable.

Our 4-point plan
for your success

Our interdisciplinary team of scientists and engineers, lead auditors and an occupational safety specialist look forward to sharing their expertise with you. Benefit from our professional services, tailor-made training opportunities, and established network of experienced specialists.

1

Consultation

regarding the development, manufacture and authorisation of the products: We show you paths and procedures that will help you reach your goal without any detours.

2

Implementation

of your projects: Our experts complement your existing resources and work together with your team to implement projects.

3

Training

for your staff: Get your teams ready for their work with tailor-made in-house seminars and workshops.

4

Sustainability

for long-term success using your quality management system: We support you with training opportunities on the latest topics, during internal audits, during supplier qualification and when continually developing your processes.

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Highlights from our seminars

Basic seminar on medical devices

This seminar covers the basics of medical devices that previously fell within the remit of EC Directives 93/42/EEC and 90/385/EEC and now fall under the remit of European Regulation (EU) 2017/745. It is intended to provide an insight into the most important areas within the legal requirements for medical devices in Europe and establish a link to practical work.

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Medical device consultant as per Section 83 of the German Medical Device Law Implementation Act (MPDG)

In accordance with the German Medical Devices Act (MPG), medical device manufacturers are obligated to ensure that medical device consultants and safety officers as per Sections 30 and 31 of the MPG have completed a sufficient level of training. This seminar is intended to provide employees in these roles with the knowledge they need to confidently work with the MPG and to explain their tasks a...

Basic seminar on risk management – Module 1

At the heart of the legal requirements for medical devices in Europe are the fundamental safety and performance requirements (previously known as essential requirements) that must be met by all medical devices. As a basis, they require a risk management system that covers all phases of the product life cycle to be implemented by the company. The prospective identific...