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.

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

Inhouse & Supplier Audits

Communication with Notified Bodies & Authorities

Avoiding Product Recalls

Technical Documentation Assessment

Optimization of Processes according to ISO/IEC Specifications



EU Authorized Representative

Person Responsible for Regulatory Compliance (PRRC)

Our Core Services

EU Authorized

Person Responsible for Regulatory Compliance (PRRC)

Internal and Supplier Audits

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.

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

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Get your Medical Device ready for the Market!

Brussies Lifes Sciences GmbH
Klenzestrasse 13
80469 Munich, Germany

Phone: + 49 (0) 89 – 92 333 197
E-Mail: info@brussies-ls.com

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