We help Companies to save Money, Time and Hassle in getting Medical Devices approved in the EU, UK and CH
Find out what your Medical Device needs to get approved quickly and successfully.
Our Core Services
EU Authorized
Representative
Person Responsible for Regulatory Compliance (PRRC)
Internal and Supplier Audits
Getting a Medical Device approved in the EU, UK or CH can be tough, time-consuming and confusing. But it does not have to be!
We help you with the following topics:
Approval for your Medical Device
Post Market Surveillance & Vigilance
Regualtory Affairs & Quality
Management
Inhouse & Supplier Audits
Communication with Notified Bodies & Authorities
Avoiding Product Recalls
Technical Documentation Assessment
Optimization of Processes according to ISO/IEC Specifications
GAP
Analysis
Risk
Assessment
EU Authorized Representative
Person Responsible for Regulatory Compliance (PRRC)
We help Companies to get their Medical Devices approved and we take care of it during the whole Product Livetime
The most valuable asset a company has is its people. People who use the products, people who benefit from the products and, of course, people who are responsible for bringing the products to market. With motivated and skilled people, your products will have an outstanding impact on the market and will continue to do so in the future.
However, having a good and stable quality and regulatory strategy to achieve and maintain product compliance is mandatory. We’re happy to keep an eye on your products from a regulatory and quality perspective, not forgetting your business partners (e.g. suppliers) and, of course, your colleagues, wherever they may be.
As a current Notified Body Authorised QMS/RA Auditor with over 14 years QM & RA experience (the last 8 years as a freelancer) I have seen a lot of great doing companies that have mastered the challenge of continuous quality management improvement and regulatory product compliance while staying competitive with their products. I would like to share with you my soul driven mission and experience to create a good QM & RA environment with a highly motivated team and thus wonderful products.
Either way, we look forward to working with you to get your products ready for the European market. It is only an e-mail away.
Profile of Shareholder-Managing Director Dennis Brussies
Briefly
- Notified Body 0123 (TÜV Süd Product Service GmbH) authorized MDR/MDD/ISO 13485 Auditor
- Project Manager
- Dipl.-Ing. (FH) International Manufacturing Engineering
- International Welding Engineer
- Allrounder with proper hands-on-mentality, problem taker and solver with strong team player and team leader skills
Detailed
Profession
| since 01/2015 | Brussies Life Sciences GmbH, Ingenieurbüro Brußies Shareholder-Managing Director Providing Services in the field of Project Management, Quality Management and Regulatory Affairs, ISO 13485 Certification, UKCA Mark, MedDO, Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (EU-MDR) -> especially QMS Auditor, PRRC & EU-REP |
| since 06/2023 | Visiting Professor Hochschule Furtwangen, Germany |
| since 01/2021 | TÜV SÜD PS GmbH authorized MDR/MDD & ISO 13485 Auditor TÜV Süd Product Service GmbH Auditing companies according to MDD/MDR & ISO 13485 and ISO 9001 |
Why Choose Us
We are passionate.
-> proper hands-on mindset
We are professional.
-> no shilly-shally attitude
We are there for you.
-> no call center, no chat bots
Brussies Lifes Sciences GmbH
Klenzestrasse 13
80469 Munich, Germany
Phone: + 49 (0) 89 – 92 333 197
E-Mail: info@brussies-ls.com
