Our services

Your Solution for Regulatory Approval, Market Access & Sourcing

1- MDR-IVD & Regulatory Affairs

Obtaining regulatory approval for medical devices and in vitro diagnostics (IVDs) under the EU MDR (2017/745) and IVDR (2017/746) can be complex and time-consuming. We guide you through the entire process—strategically, efficiently, and tailored to your specific needs.

With a valid CE marking, your products gain access to the entire European Economic Area (EEA) and other key global markets—boosting trust among distributors, healthcare professionals, and investors.

Our regulatory services include

Preparation, review, and optimization of technical documentation

Preparation, review, and optimization of technical documentation

Support in selecting and communicating with suitable Notified Bodies

Risk classification, clinical assessment and vigilance strategies

Support in selecting and communicating with suitable Notified Bodies

Your Advantage:
Regulatory confidence and market access from a single source—compliant, cost-effective, and future-ready.

Our Core Regulatory Services at a Glance

Accurate classification is the first step toward CE certification for medical devices and IVDs. We provide regulatory-compliant classification, complete risk assessment documentation, and identify potential compliance gaps in your technical files or quality system.

A functioning QMS is a prerequisite for CE certification. A functioning QMS is essential for CE marking. We assist manufacturers, importers, and authorized representatives with QMS development, system optimization, and audit preparation in accordance with ISO 13485 and MDR/IVDR.

We create, review, and update your technical documentation in line with MDR Annex II/III. We create, review, and update your technical documentation in line with MDR Annex II/III.

Our services include
Preparation of SSCP, PSUR, PMSR
Vigilance reporting support
Preparation of SSCP, PSUR, PMSR
We prepare or update Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) according to MDR/IVDR. We prepare or update Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) according to MDR/IVDR.

As your Authorized Representative in the EU, we act as your official liaison with authorities and Notified Bodies—ensuring full regulatory compliance. We also help you establish strong distribution partnerships in the Middle East, North Africa, and Asia through our established regional networks.

2. FDA Approval & Regulatory Consulting for the U.S. Market

Your Path to U.S. Market Entry – with Trusted On-the-Ground Support

In addition to our MDR/IVDR expertise in Europe, we offer full-service support for medical device and IVD manufacturers entering the U.S. market. Working closely with experienced consultants based in the United States, we help you navigate the entire FDA approval process—whether via 510(k), PMA, or De Novo.

Our services at a glance

Analysis of the US approval requirement for your product

Support in the creation of FDA-compliant documentation

Coordination with experienced US consultants on site

Strategic planning of pre-submission meetings and submissions

Consulting on UDI, labeling & QSR (21 CFR Part 820)

Ideal for

Manufacturers who want to serve the EU and US markets in parallel

Distributors focusing on import/export of US products

Start-ups with a global expansion strategy

3. Strategic brand representation & sales for manufacturers

Successfully entering new markets – with local partners & international strategy

Manufacturers who want to bring their medical devices or IVDs into new markets such as the United Arab Emirates, Saudi Arabia, Oman or North Africa need more than regulatory approvals – they need reliable distribution structures and a strong brand presence.

We take care of it for you

the targeted search, qualification and coordination of professional distributors and sales partners

if necessary, the function as Authorized Representative

• the strategic positioning of your brand including image management and digital marketing

Through our local network, our cultural understanding and our experience in international market access, we ensure a smooth, legally secure and economically viable entry into new markets.
Would you like to know in which regions your product has the best market opportunities? Contact us – we will analyze your potential and develop a customized market entry strategy together with you.