The Expert Exchange

Serious Q&A for equally serious medical device professionals.

Find real-life solutions to real-world problems. The medical device industry’s leading experts and authorities open up and share their experience, knowledge and sometimes, downright frustration with the one subject they hold dearest: medical devices. From best practices to latest techniques and standards; if you got the question, here’s where you’ll find the answer.

 

Latest posts:


ISO 14155/2011 Device deficiency definition: investigational device and comparator?

 

ISO 14155/2011: Signatures on the IB and CIP?

 

ISO 14155/2011: Difference between draft and final release?

 

When will ISO 14155 become a harmonized standard?

 

When will authorities begin applying the new standard?

 

Are Annexes of the standard mandatory or optional?

 

Does ISO 14971 reference ISO14155?

 

ISO 14971: Include the full risk analysis in the submissions?

 

Does ISO give guidance on deviations?

 

Point of enrollment?

 

Where can we get a copy of ISO 14155?

 

Sponsors, Monitors and Case Report Forms?

 

Sponsor responsibilities: documentation?

 

Regarding the requirement for 13485

 

So I understand from your answer that EC's will not request certificates?

 

Investigator competency: responsibility of the sponsor?

 

Is there a chance that the ISO 14155 will be totally rejected?

 

Is the new ISO also applicable for older, ongoing studies?

 

Is FDA likely to accept this ISO version?

 

When do you expect notified bodies to require this compliance?

 

Are standard SAE forms provided in the ISO 14155?

 

Determining qualification to obtain informed consent?

 

MedDRA coding of treatments linked to an AE or SAE?