Requirement for Sterilization Validation completion before issuance of ISO cert



Hi all,

I'm a new poster, hoping you can help. We are a small start up Class III medical device manufacturer - all manufacturing, sterilisation, packaging is outsourced. We had successful Stage 1/2 audits and are in the middle of our micro assessment.

Assessor has stated that she cannot approve certificate scope to include sterile product unless product sterilisation validation is completed. Very surprised by this, my understanding was the audit was to confirm that there was the system in place for manufacture of a sterile product we have QMAs in place with all our suppliers, these suppliers are also customers of the same NB all with ISO certification. We have provided our procedures describing NPD and design transfer and requirement for validation to be completed before product release. For me this is something that should be reviewed as part of the CE-marking process.

Does anyone else have experience of having to provide validation documents at this early stage? We are still in prototyping phase, CE mark not being sought until 2020, FIM anticipated for next year and sterilisation protocol currently in draft (and reviewed by the reviewer).

would welcome your comments.

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