Full-service offerings for your medical devices

Classification, CE marking, technical documentation? Diapharm will help. We assist and provide services for manufacturers of non-active and active medical devices, including in vitro diagnostics (IVD) and combination products, for all aspects of regulatory and practical issues:

• Feasibility studies, clinical evaluation
• Consulting along the development process and advice on the implementation of normative requirements
  
• Creation of device master records (technical documentation), required and product labelling
• Conduct conformity assessment
• Batch release according to article 1, 2(f) of the Medical Devices Directive (93/42/EEC)
• Set up quality management systems including risk management

Diapharm is there for its customers over the entire life cycle of the product and, if needed, will assume all regulatory and organisational responsibilities and duties:

• Finding the right contract manufacturer and accredited testing laboratory
  
• Taking on legal functions in accordance with, especially, the German Medical Devices law (Medizinproduktegesetz): safety officer, manufacturer, etc.
• Ensuring post-marketing surveillance of your medical device
• Regulatory support and change management
  

Our team is made up of experts from the areas of regulatory affairs, clinical research, quality and business development. This wide-ranging expertise makes us one of the leading full-service providers in the healthcare industry – for every type of product category. Contact us!