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 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.
Our Profession
Customer and Main Projects
| B.Braun Melsungen AG https://www.bbraun.com | Senior Advisor Notified Body (NB) Topics, Deputy/Interim Program and Project Manager B.Braun Melsungen AG – Regulatory Affairs and R&D Department Product scope: Infusion & Pain Therapy, active & none-active devices Class IIa/b & Class III (acc. to EU-MDR & MDD) Jul/2023 – Jun/2024 |
| Karl Storz SE & Co.KG https://www.karlstorz.com | Senior Regularoy Affairs Manager Karl Storz SE & Co.KG – Regulatory Affairs Department Product scope: active/none-active devices Class I and IIa/b (acc. to EU-MDR & MDD) intended for operating room environment Jan/2020 – Dec/2022 |
| Stryker Leibinger GmbH & Co. KG https://www.stryker.com | EU-MDR Implementer Stryker Leibinger GmbH & Co. KG – Regulatory Affairs Department Product scope: active/none-active devices Class I and IIa/b (acc. to EU-MDR) intended for operating room environments Oct/2018 – May/2020 |
| Trumpf Medizin Systeme GmbH + Co. KG / Baxter https://www.baxter.com/ | R&D Supporter and Task Force Lead EU-MDR/ISO 60601-1 Trumpf Medizin Systeme GmbH + Co. KG/Hill-Rom – R&D/RA/QM Department Product scope: active and none-active devices class I (acc. to EU-MDR) intended for operating room environments Aug/2017 – Sep/2018 |
| Roche Diagnostics GmbH https://www.roche.com/ | Single Point of Contact for SHE Support in GMP environment Roche Diagnostics GmbH – SHE (Safety, Health, Environment) Department SPOC within reconstruction projects Dec/2016 – Jun/2017 |
| Bombardier Transportation GmbH | Quality and Regulatory Affairs Engineer Bombardier Transportation GmbH – Quality Management Department Jul/2015 – Mar/2016 |
| Linde AG | Quality and Regulatory Affairs Engineer Linde AG Engineering Division, Pullach, Bavaria, Germany Quality Assurance/Quality Control & Manufacturing department Mar/2012 – Jun/2014 |
| DEKRA Industrial GmbH | Engineer in the field of Industrial Safety and Operating Reliability DEKRA Industrial GmbH, Stuttgart, Baden-Württemberg, Germany Jun/2009 – Feb/2012 |
Profile of Dennis Brussies
Profession
| 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, Person Responsible for Regulatory Compliance (PRRC) & European Authorized Representative (EU-REP) since Jan/2015 |
| Hochschule Furtwangen, Germany | Visiting Professor since Jun/2023 |
| 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 since Jan/2019 |
Advanced Training and Professional Studies
- Quality Management (QM) (Lead) Auditor according ISO 13485/ISO 9001 with TÜV SÜD PS GmbH incl. e.g. MDD, MDR, Conformity Assessment Procedures, Risk Management, Software, Cyber Security, Usability, Nano Materials, Electrical Safety, Biocompatibility, Post Marked Surveillance, CAPA-Management, basic level in Clinical Evaluation
- Quality Managment Specialist (QMF), Quality Management Representative (QMB), Quality Management (QM) Auditor with TÜV according to ISO 13485:2016 TÜV
- Manager Regulatory Affairs Medical Devices International TÜV
- CE-Coordinator TÜV
- Authorization program for pressure vessels with DEKRA SE acc. Pressure Equipment Directive, machine & device security acc. BetrSichV/DGUV, Dangerous Goods Transportation and Machinery Directive
- International Welding Engineer at SLV Halle, Saxony-Anhalt, Germany
- University degree (Applied Sciences) as International Manufacturing Engineer
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
