Our company has bought few Advisera documents regarding ISO 13485 risk management and clinical evaluation. Can I ask you a question I have been struggling to find the answer? How often should those documents be updated? Clinical evaluation plan and review; risk management plan, file, review? We are producing class I medical devices.
We are working on the procedure for Document and Record Control and some questions have come up.
Can you help explain what types of records need to be recorded?
Do we need to list all the types of records and why would we need it?
Would a CAPA be a record or a document?
Can you please direct me to a part in regulation on lab reagent equivalency requirement?
I am involved in project to asses equivalencies of reagents used in lab but not entirely sure where to go for information on requirements for performing equivalency study of reagents for analytical test method
What are the ISO 13485:2016 regulatory expectations around distributors?
Around distributor qualification, management, customer complaints, supply or QA agreements,
Is your toolkit for MDR compliance optimized for software as a medical device?
Under what circumstances a medical device which has already been put into service can be returned by the user or patient to the manufacturer to be repaired or modified? Does this trigger any documentation or procedures to be in place? What are the risks?
For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?
How to audit and create a checklist for medical device labeling including advertising and claims?
What would be the most difficult issue and challenge during initial implementation?