Tag Archives: medical device summit

Devine Guidance

IVDD Annex IX

By Dr. Christopher Joseph Devine

The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”

The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”

Continue reading

Devine Guidance

IVDD Annex VIII

By Dr. Christopher Joseph Devine

This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.

This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.

Continue reading

Devine Guidance

IVDD Annex VI (EC Verification)

By Dr. Christopher Joseph Devine

Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.

Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.

Continue reading