Full batch traceability is ensured for all our batches, from the materials delivered to us by our suppliers to the finished products we deliver to our customers. Each batch of products that leaves Medistad is provided with a Certificate of Compliance. This Certificate represents a batch manufacturing record and confirms that a batch has been manufactured in accordance with all applicable specifications: all known variables that influence the performance of the finished product have been controlled to such an extent that optimal assurance can be issued regarding conformance to requirements.

 

As a department independent from manufacturing, Quality Control has the responsibility to check whether all procedures and instructions applicable to a product are applied during manufacturing. Tests are performed to confirm that products fulfil their requirements and that technical processes are performed within their specific boundaries. Furthermore, Quality Control will continuously encourage staff to apply procedures and deliver quality.

In Process Control

Quality in manufacturing is monitored and realised first and foremost by our production employees. Each product goes through their hands or is created on their machine. This is as close to the product as you can get. Therefore, our production employees are given an important part in monitoring quality by means of In Process Control.

Quality Engineering

During introduction of a new product at Medistad, we aim at building quality into the product. New applications will be checked against prevailing standards and a failure mode and effect analysis (FMEA) will be performed involving key aspects such as the materials, the manufacturing process and the actual product application. Our Quality Engineering department will translate new applications into functional requirements and test protocols, and supervises the process of risk assessment to exclude any possible and unacceptable threat of faulty products getting onto the market. In addition to our experience and know-how, extensive testing and validation of new materials and new connections are important ways to release new developments for regular production.