Thoughtful product development, fast market access, and comprehensive assumption of responsibility for medical devices.
Classification, technical documentation, CE marking: As the legal manufacturer, Diapharm assumes all regulatory responsibilities and brings medical devices to market quickly and efficiently.
The medical devices market is growing — and so are the regulatory hurdles: CE marking is complex, conformity assessment takes time, and quality and documentation obligations tie up resources.
With MDR and IVDR, requirements continue to rise. Manufacturers are faced with new classification rules, the obligation to implement a quality management system, and the challenge of involving scarce designated bodies. The result: delays, additional costs, and high uncertainty when entering the market.
Diapharm helps companies meet MDR and IVDR requirements effectively and efficiently, ensuring products are introduced to the market without delay.
across all risk classes, including medical devices and combination products, are managed and overseen by HÄLSA as legal manufacturer.
We take responsibility.
are maintained on the market and managed from a regulatory perspective by HÄLSA as European, Swiss, or UK Representative.
We make things possible.
were released to the market by HÄLSA as legal manufacturer in 2024.
We lay the foundation for success.
Expertise that leads to successful products.
Taking Responsibility
Diapharm takes on the role of responsible manufacturer under MDR and IVDR, creating the regulatory foundation for the successful commercialization of your products. So you can place the regulatory responsibility in safe hands.
Learn more
Product Development
Diapharm assesses the regulatory feasibility of your product idea and develops a regulatory roadmap for certification. So you can bring your products to market with efficiency.
Learn more
Clinical Evaluation
For medical devices, a clinical evaluation is a mandatory requirement of the Medical Devices Regulation (MDR). In-vitro diagnostics (IVD) must undergo a performance evaluation. Diapharm knows these requirements well, and has the experience to handle them. So your product is optimally positioned from a clinical perspective.
Learn more
Clinical Trials
Your own clinical data provide direct proof that a product is safe and effective. Innovative product features can be specifically demonstrated and documented. Diapharm assumes full responsibility as the sponsor and supports you during the execution of clinical trials. So your clinical data become a unique selling point.
Learn more
Conformity Assessment
To obtain approval for medical devices and in-vitro diagnostics, a positive conformity assessment procedure is required — one in which the product is reviewed for safety and performance. Once this is complete, CE marking follows. Strategic decisions must be made early in the process to set the course for subsequent product success—and Diapharm knows what it takes. So your medical device is positioned for success right from the start.
Learn more
Maintenance
Diapharm ensures monitoring and maintenance of medical device and in-vitro diagnostics conformity throughout the entire product life cycle. So your products stay safe and successful in the long term.
Learn more
Drug-Device Combination Products
When developing combination products, two regulatory worlds collide — pharmaceuticals and medical devices. Diapharm knows how to align these requirements intelligently, ensuring that products are successfully developed. So the market success of your combination products is never left to chance.
Learn more
Overcoming capacity bottlenecks, leveraging synergies, and accelerating market entry
Efficient, experienced, and MDR-compliant.
A pragmatic, business-focused approach to these challenges is in demand. Diapharm helps companies meet MDR and IVDR requirements effectively and efficiently — so products reach the market as quickly as possible.
Since 2005, HÄLSA Pharma GmbH has assumed regulatory responsibility as legal manufacturer for medical devices. Companies place all device-specific regulatory matters in HÄLSA’s hands, allowing them to focus entirely on their core business.
In times of limited notified body resources, HÄLSA speeds up market access for products significantly. With MDR certificates across numerous product categories, HÄLSA can leverage the MDR “New Approach.” Medical devices can be placed on the market immediately. The only prerequisites are a declaration of conformity issued by HÄLSA, plus a notification of change and submission of technical documentation to the notified body.
Capacity bottlenecks and differing interpretations of regulatory requirements by notified bodies are possible to overcome—both for transferring legacy devices into MDR and for new developments.
HÄLSA Pharma GmbH is a subsidiary of Diapharm GmbH & Co. KG.
A role at Diapharm combines communication with clarity, reliability with empathy, and precision with pragmatism.
You think holistically, across disciplines, and in a results-oriented way? You’re good at analyzing, assessing and making decisions? You understand people — both clients and colleagues? You communicate with confidence — both in German and English?
Then you’ll find exactly the right role at Diapharm.