In order to be able to effectively compete, successful and trouble-free medical technology product certifications and audits are essential for our customers. Newly developed products that are already established on the market need to be properly validated with respect to their cleanliness, packaging and sterilisation. At the same time, medical product manufacturers are faced with major challenges such as compliant evidence provision and the documentation of validations.
For many years, we at steripac have reliably accompanied our customers with a proven project methodology in these processes. We know what needs to be set up for notified bodies in terms of validations, we are familiar with rules and standards, and we keep abreast of new guidelines for both national and international markets.
For all cleaning, packaging and sterilisation processes, we develop efficient validation plans that comply with the laws, minimise risk and which are still economically viable. The implementation is done on site with our certified systems and equipment, or with accredited laboratories.
We provide our customers with a total package which contains all of the necessary documents, reports and evidence for the authorities.
With our extensive experience from a variety of validation projects, we understand the unique challenges that arise during the lifecycle of products. Procedures must be revalidated after defined timeframes, and material changes also require an adaptation of the processes with a renewed validation.
We always remain in close contact with our customers so that they remain certain that their validation obligations are continuously being met. We see ourselves as a pulse generator which provides security. We feel responsible, request statements of changes with materials and processes, and remember the validation of upcoming revalidations well ahead of time. This gives our customers a sense of relief and puts validation projects in successful stead.