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I wonder if you can help me with one question, please? I have read that ISO 13485 2016 places emphasis on post-market surveillance, and this terms appears in the glossary. Yet I cannot find this term in the text of the standard, although I suppose the meaning is in Section 8. Is there anywhere in the standard that actually asks for post market surveillance please?
Vigilance is one requirement for MDR but cannot be found in the template. Is Vigilance included in 18_Post_Market_Surveillance?
I would like to ask about the documents included with the "ISO 13485 & MDR Integrated Documentation Toolkit toolkit with expert support"
We are a company with class I medical devices and are in the process of creating the SOPs to be compliant with MDR
Are your SOPs geared towards medical devices with higher classes (therefore more detailed and technical) or are they also suitable / can be modified for class 1 devices
For class 1 medical devices, we need to do SOPs for regulatory strategy; final product release; vigilance; and field safety corrective action. I don't seem to see those in the list of SOPs via the preview, and wanted to check if those are included or under a different name?
Also, does your company provide a way to identify in the SOPs which part of the relevant SOP is necessary for Class 1, and which parts are not? As we will likely only want to include the necessary info and not give extra unnecessary info.
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?