Product Development
Integrating regulatory expertise from the very beginning of product development provides a decisive advantage. Diapharm supports clients in the early stages of product development, clarifies borderline classification questions, and develops the optimal positioning strategy.
If proprietary clinical data are needed for product realization, Diapharm takes over and guides clients through the entire clinical trial process.
Confirmity Assessment of Medical Devices
Diapharm supports manufacturers in the certification of medical devices and in vitro diagnostics. In preparation for certification, all required documents must be compiled, resulting in the technical documentation for a medical device. Depending on the product’s classification, the requirements — and therefore the content — of the technical documentation will vary.
In confirmity assessment procedures, Diapharm manages communication with the respective notified bodies and authorities on behalf of clients.
Involvement of a Notified Body
For medical devices in risk classes Is, Im, Ir, IIa, IIb, and III under the MDR, as well as IVDs in classes A, B, C, and D under the IVDR, involvement of a Notified Body is mandatory during the conformity assessment.
To assume manufacturer responsibility on behalf of clients, Diapharm’s subsidiary HÄLSA Pharma GmbH works with a Notified Body that is fully accredited for all MDR product groups and has obtained an EU Quality Management Certificate under Annex IX MDR in 2022.
Quality Management Systems for MDs and IVDs
Diapharm supports clients in setting up and maintaining quality management (QM) systems for medical devices in accordance with the MDR, IVDR, and ISO 13485. This includes preparation for audits by Notified Bodies and business partners, regulatory inspections, adapting systems to changing requirements, and reviewing manufacturing processes (compliance checks).
Establishment of a quality management system for medical devices in line with the MDR, IVDR, and ISO 13485, including preparation for certification
Assessment and modernization of existing quality management systems or expansion to meet medical device requirements
Evaluation and support for quality assurance requirementsg
Conducting audits and self-inspections
Supporting audits by Notified Bodies and regulatory inspections
Diapharm ensures that clients have a quality management system for medical devices that aligns with their overall strategy. QM manuals and Standard Operating Procedures (SOPs) are developed so that standardized processes reflect each company’s individual workflows, remain compliant with the MDR or IVDR, and are at the same time as efficient as possible.
