ISO 13485 & EU MDR - Expert Advice Community

Do manufacturing of medical face mask require clean room?

Document Control Numbers (Doc Code)

Having purchased the ISO13485 toolkit, I have a couple of questions related to Document Control Numbers (Doc Code).
We have a mature system, but it is due for overhaul and simplification. But because of our mature system, for most of the documents in your system we have existing Document Control numbers, many with considerable revision history. My preference is to renumber the documents to the Doc Codes in your List of Documents. is it considered best practice to include the Doc Control Number in a Document Change but keep the revision number in sequence? For example: Doc 00 (Procedure for Document and Record Control) Rev 1 (if we were implementing your document as a new document) is fine. But we are replacing our document 423-01 Rev 4 with this document. So would we do a Document Change that includes the renumbering of this document to 00, but use Rev 5 to clarify that this is not a new document (even though a new Doc Control Number)? Or is there a better approach to this?

Differences between ISO 13485:2003 and ISO 13485:2016

1. What are the exact differences between ISO 13485:2003, ISO 13485:2016?

2. What portions of FDA cGMPS, are being revised to comply with ISO 13485:2016?

15223-1 and 13485 certification question

Do i need to purchase iso 15223-1 in order to comply with a medical device app? Furthermore can the iso 13485 certification and the CE certification be done by the same organization?

Lot number coding

Our company recently purchased Advisera’s package of ISO 13485 templates for implementation in our company as we are starting producing class I medical devices (surgical gowns) to supply the Portuguese market as soon as possible.

I’m aware you provide a meeting to discuss doubts about the templates provided, but at the moment I’m in a hurry to solve an issue regarding the lot number coding and I didn’t find any information about that in the package purchased.

Is there any template to help us code the lot/batch number of a medical device or mandatory information that we should include in that code? We want to allocate that code automatically, but we don’t know what requirements to demand from the automatic batch number allocation.

Would you kindly help me with this matter?

ISO 13485 implementation duration

Small contract engineering firm, 10 employees. Decades of experience in product development but little in med devices. Starting from nothing, about how long should it take to achieve 13485 certification using the right consulting firm to assist?

Can contract manufacturer exclude validation from their scope?

I just want to know if it is possible that a contract manufacturer can exclude validation from their scope?

Preparing site for first-time ISO 13485 audit

How to prepare the site for the first-time audit for on 1ISO 13485?

Guidelines for complying with ISO 13485 regarding validation and computerized system validation

What guideline do you recommend to use to comply with ISO 13485 regarding validation and computerized system validation. We will not need to comply with FDA guidelines. Please share any recommendation.

Calibrating instruments after due date by fixing the window period

I have one doubt, can I calibrate the instruments after the due date like by fixing the window period. Is it acceptable?
Example: Calibration due date is 10 September. the window is 5th to 15th September, can I calibrated 12th September after the due date.