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Qualification for Medical Device Industry

Qualification and validation ensure the quality of medical devices

Qualified equipment and validated manufacturing processes ensure reproducible high quality of medical devices.

Medical device manufacturers must ensure that their medical devices meet high quality standards to satisfy regulatory requirements and protect patients. It is therefore advisable to comply with these already during development and to consider them in all further process and manufacturing steps.


After successful design verification and design validation, during which we can advise and accompany you, the manufacturing of the medical device is the next hurdle to overcome. The manufacturer has to ensure that the quality of the product is reproducible.

Requirements for medicinal products

To ensure this, it is necessary to comply with the valid regulatory requirements of Din EN ISO 13485, MDR 2017/745, IMDRF and FDA, which require the validation of the associated processes in addition to the qualification of the manufacturing facilities and quality control equipment.

Despite these requirements, the implementation of validation and qualification in companies often takes place only partially. Either the medical devices are manufactured with unqualified equipment or the manufacturing processes are not validated. Reasons for this include a lack of resources and a sprawling and costly scope of qualification and validation.

To be time and cost efficient here, our experts take a process-oriented (definition of the relevant process steps) and a risk-based approach (process risk analyses, technical risk analyses). All critical aspects related to the medical device classes are thus addressed, but the scope for qualification and validation is reduced to what is necessary.

Depending on the planned application, other current standards such as GMP rules must be applied during qualification. Medical devices scheduled to be approved in the USA must meet the requirements of the FDA. In this case, qualification must be executed in accordance with 21 CFR 820.1 cGMP (current Good Manufacture Practice). In addition, the use of GMP regulations is also recommended for combination products (drugs with medical devices).

How we can support you

Based on your requirements, Valicare offers services ranging from the execution of individual subtasks to superior project management and complete execution of qualification and validation. Often, projects first start with a recording of the target/actual state (Gap analysis) in order to define the gaps and the upcoming tasks derived from this. We have comprehensive qualification and validation concepts in the drawer and our services include:

  • Listing of all process steps and creation of a process risk analysis
  • Preparation of a validation master plan
  • Preparation of technical risk analyses
  • Initial qualification plans for facilities and equipment.
  • Implementation of the qualification (DQ, IQ, OQ and PQ)
  • Preparation of validation plans (design, process, cleaning, method, and computer system validation).

We advise you and work with you to create the optimal quality concept for the manufacture of your medical device. 

Further services for DIN EN ISO 13485 compliance and quality risk management for medical devices can be found here: Medical Device Compliance.

Ellen Sons Brinkmann

First consultation free- contact us now!

Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com