Your competent partner in medical device technology.
Since 2006, we provide high-quality services for the medical device industry in order to support our customers in dealing with constantly growing regulatory requirements.
With foresight, we are constantly adapting our services to prepare our customers individually and optimally for new requirements. Currently, we have expanded our product portfolio to include services related to the implementation of the requirements of the Medical Device Regulation MDR. It is accompanied by another key topic of MDR, the Post-Market Surveillance (PMS) service package. The usual services clinical evaluations, biological evaluations, risk management, preparation and maintenance technical documentation and the support in CE certification are of course still available. To cover special challenges in MDR, we have partially extended them in order to identify possible problems in advance and to make appropriate preparations at an early stage. Since this strongly depends on the individual products, we were only able to address some of them in the presentation of our service packages. Contact us to determine your individual requirements.
We provide customized solutions, adapted to your needs, your products, possible OEM/PLM constellations and your target markets. Our outsourcing solutions are designed in a way that you can easily and reliably complement the competencies in your company.
What distinguishes us?
Key documents and competence for CE certification from long-time experienced specialists: clinical evaluations, post-market surveillance, risk management, preparation or revision of technical documentation, support during the transition phase to MDR, communication to your Notified Body.
“Success is for me when a project is completed and the customer is satisfied, when I brought the company a step forward through my work. And this does not depend on the product itself or the size of the company. Some customers thank you and tell you that you have done a good job. That makes me particularly happy. Some recommend me to others. This also confirms me in my work and the good conception of my service packages.”
Dr. Gabriele Heitner
With 12 years of professional experience in industry specialist and management positions and 12 years in her own company for services in medical device technology, she is the perfect contact for the interests of industry.
From her affinity for medicine, the graduate physicist completed a German-Italian double doctorate in medical physics. In connection with her education, she spent several years at international research facilities.
In November 2006, she founded her own company HeiMed® to support medical device companies with her specialist expertise. Especially for the medium-sized structured companies, typical in the medical device sector, it is often more economical to outsource special services.
The long-term success of her company confirms her business concept. Since the foundation of her company she is familiar with ophthalmology and has been working on projects in this field ever since. Gradually, other areas joined their competencies, such as cardiology, orthopaedics or dermatology. In principle, however, her service packages are not restricted to certain medical areas, as they are designed across disciplines.
Highlights:
- Organisation of the CE study of an outstanding innovative product in ophthalmology for its market launch.
- Successful listings of medical devices on the list of products reimbursed by the German heath care system (G-BA listing).
- Product registrations in more than 50 countries, among them China and Taiwan.