Innovate on a Safety-Focused Regulatory Foundation

Use our pragmatic processes to implement your ideas

As a mid-sized manufacturer and service provider, we rely on lean and effective processes and find pragmatic solutions to put our and our customers’ projects on a secure and compliant footing – from QM systems and technical documentation to approval strategies.

Streamlining regulatory compliance to simplify approval and market entry

We are not just consultants; we are a development service provider, which means we face the regulatory challenges of high-value medical devices firsthand, multiple times a year – both with our own products and across more than 300 successful client projects so far. Our entire development process is built around creating approval-ready documentation and a streamlined organizational structure. This hands-on experience allows us to provide our clients with precise, tailored strategies at every stage of their project lifecycle, ensuring their products can successfully enter markets in Asia, the US, and Europe.

Set up for approval and easy to manage for the entire lifecycle

Whether you’re ISO 9001 certified or already have multiple medical devices on the market, we provide comprehensive support. From building or restructuring your QMS, to developing extensive regulatory strategies for FDA and CE approvals – we’ve got you covered. And we’ll guide you every step of the way, whether you need assistance with technical documentation or help ensuring all your medical devices are MDR compliant.

Creation & maintenance of technical documentation

Technical Files for Class I, IIa, IIb, III

Good documentation should start on day one and be fully integrated into planning. We provide comprehensive, compliant technical documentation with clear, easy-to-use instructions to minimize errors.

Our experts can help you implement efficient document management so that all stakeholders have quick access to relevant information.

Standards & document review
Technical file development
Specifications & functional description
Design & risk assessment
Labeling & instructions for use
Complete life-cycle support

MDR gap analyses & MDR transfer

Supporting Legacy Devices and new Approvals

The transfer of valuable, older medical devices as well as the implementation of the MDR requirements pose major challenges for companies.

We help to identify compliance gaps at an early stage and rectify them in a targeted manner. This ensures product quality and increases their safety, thus avoiding delays in approval.

Safety and performance requirements (GSPRs) and classification rules
Regulatory review & updates
Identifying & planning of required studies
Requirements of the Notified Bodies
Updating the status of standards

Approval strategies for active medical devices

FDA, MDR and additional markets

The approval of Class I to III medical devices is often a challenge, especially for smaller or inexperienced companies. Risks of delays and subsequent requests can be minimized with a focused strategy and proactive preparation.

We can help you with detailed test and study planning, as well as argumentation with your notified bodies.

Classification in risk classes
Regulatory strategies for CE and FDA
Clinical studies for safety and efficacy testing
Technical documentation for design and risk management
Verification, validation and risk management

Not only taking care of your products – but your whole system

Our consulting services go beyond ensuring the compliance of your products. We focus on building and optimizing a robust, efficient system that enhances overall quality and simplifies regulatory adherence. We provide extensive support for your company and suppliers to meet standards, minimize risks, and ensure the effectiveness of your processes. With us, you are not just managing quality – you are mastering it.