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Helping your medical devices achieve long-term success
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Projects and consulting

Workshops and seminars

News from the world of medical devices

Latest publications

 

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EU - new EUDAMED versions published

The EU has made available a new version of EUDAMED in the productive (v2.11) as well as the playground (v3.4) version. For both databases an “Information Centre” is available (productive version, playground version) that contains general information and documentation (e.g, user guides).

UK - Extension of deadline for placing CE-marked devices on the Great Britain market

In an amendment to the “Medical Devices Regulations 2002”, the timelines for placing CE-marked medical devices and IVDs on the Great Britain market are extended - depending on the class and conformity assessment procedure up until June 30th, 2030. The MHRA has prepared a respective infographic.

The MHRA has published a guidance document detailing their position concerning the adapted MDR transition periods resulting from Regulation (EU) 2023/607.

EU - Q&A document on changed transitional period published

The EU has published a Q&A document dealing with answers to important questions on the changes to the MDR and IVDR transitional arrangements.

EU - change of transitional provisions published

Regulation (EU) 2023/607 changing the transition timelines for MDR and abolishing sell-off dates for MDR and IVDR was published today in the official journal of the EU. Consolidated versions are not yet available for the MDR and IVDR.

The regulation enters into force with its publication and becomes immediately applicable. MDD and AIMDD certificates that were still valid on March 20, 2023, are automatically extended. For certificates that expired before that date additional conditions must be met..

EU-parliament adopts proposal to change transitional provisions for MDR and IVDR

The EU-parliamant today accepted the commission's proposal for changes to the transitional provisions, especially to Article 120 MDR and Article 110 IVDR, respectively. Consequently these changes have made a significant step towards their entry into force with the publication in the Official Journal of the European Union. The text voted on in its different language version is accessible here.

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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.

Current events
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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...

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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...

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