Manufacturers of Medical Devices, you want to validate a method according to the ISO 19227 standard?
What is a method validation according to ISO 19227?
Method validation consists of guaranteeing the performance of a method by examination and providing objective proof of its use.
Furthermore, the ISO 19227 standard is specific to the field of medical devices. Indeed, ISO 19227 describes the requirements for the cleanliness of orthopaedic implants and the validation of the cleaning processes used.
Why validate your method according to ISO 19227?
The objective of cleaning validation via ISO 19227 is to verify the effectiveness of the cleaning process in reducing physical, chemical and microbiological contaminants below a customer-defined level.
To achieve this, the evaluation and validation of cleaning methods requires a thorough knowledge of the orthopaedic implant manufacturing process in order to identify potential contaminants and potential interactions between the cleaning process, the implant materials and the environment.
FILAB supports you in method validation according to ISO 19227
FILAB offers a wide range of services, some of which are COFRAC ISO 17025 accredited (www.cofrac.fr), using validated and documented methods, helping you to bring your activities into compliance with the requirements of ISO 19227.
Thanks to its state-of-the-art analytical equipment and varied in-house skills, FILAB can assist you in validating methods in accordance with ISO 19227.
