ISO 13485 & EU MDR - Expert Advice Community

Cleaning validation SOP for orthopedic medical device

what I am looking for Cleaning validation SOP for orthopedic medical device"

Internal audit

We had an internal audit earlier this year of company QMS to  the ISO 13485:2016 and MDD 93/42/EEC, do we need to schedule another internal audit beforeQMS audit to assess company compliance with MDR? 

Orthopedic device manufacturers

Questions about ISO 13485 implementation

My company (a contract manufacturer) will, in the near future, be manufacturing and distributing (and exporting) medical devices alongside products not classified as medical devices.  We were advised to implement the Good Manufacturing Practice (GMP) and the Good Distribution Practice For Medical Devices (GDPMD). I would be very grateful if you could advise me on the following matters:

1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?

2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant,  should my company then implement ISO 13485 instead of GMP?

3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirement – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?  

4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?

Thanking you in anticipation of your kind response to my above questions.

Note: It is by chance that I came across Advisera’s publications in the web, and I found them to be very insightful. Keep up the good work.

Change request procedure

I noted there is not change request procedure or form template in the package. Is it covered in any other procedure? Also, I could not find Goods In and Goods out procedure. will these be developed. Please advice.

Legal and statutory requirements associated with ISO 13485

Am looking for the legal and statutory requirements associated with ISO 13485

Is clean room installation mandatory?

Hi there, the questions is - Does ISO 13485 depict that there has to be a clean room installed?

Information on risk classification for IVDs under new IVDR regulations

I need more detailed information on risk classification for IVDs under the new IVDR regulations. This is referring to the EU IVDR.

Requirements for custom service business to be compliant for ISO 13485

what are the requirements for custom service business to be compliant for ISO 13485?

Parameters for clean room

I am looking for parameters for clean room