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Helping your medical devices achieve long-term success

News from the world of medical devices

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EU - Update of the SCHEER guidelines for risk-benefit-assessment of phthalates

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published an update of the guidelines on the benefit-risk assessment of phthalates with carcinogenic, mutagenic, reproduction toxic or endocrine disruptive properties. The guideline can also be used for other substances with comparable properties, the presence of which above a certain threshold requires a justification according to MDR Annex I.

EU - New and updated MDCG guidance documents

In May the MDCG published several new guidance documents. MDCG 2024-6 to -9 containt templates for the (re-)assessemnt of Notified Bodies by the authorities. In addition MDCG 2022-4 dealing with appropriate surveillance of legacy devices was updated and is now available in revision 2.

EU - European parliament approves changes to MDR and IVDR

In its last session before the pending EU elections, the EU parliament approved the regulation to change MDR and IVDR with respect to gradual roll-out of Eudamed, information obligation in case of interruption of supply and transitional provisions for IVDs on April 25th. Before publication in the official EU journal and entry into force, the Council of the European Union must approve the changes.

EU - Updated list of planned MGCG guidance documents

The EU has published an updated list of MDCG guidance documents currently under development on the MDCG webpages. The list includes more than 40 entries concerning planned new guidances and updates to existing ones that are planned to be published in 2024.

EU – Update of the lists of harmonised standards for MDR and IVDR

The EU published two implementing decisions expanding the list of harmonised standards for MDR and IVDR. The decisions add 8 standards for MDR (25 in total) and 3 for IVDR (13 in total). The newly added standards address aspects of biological evaluation, processing (both for MDR), radiation sterilization and sterile packaging (MDR and IVDR). Consolidated summary lists of harmonised standards can be found on the respective EU websites for MDR and IVDR.

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...