ISO 13485 & EU MDR - Expert Advice Community

Implementation of ISO 13485

Hello! My company is a small contract engineering group that offers medical device development services. Since we are purely R&D (no manufacturing) does it make sense for us to implement ISO 13485 in your opinion? Thank you for your time.

ISO 13485 Implementation

If I have a certificate of ISO13485 (for my 1st factory) , and now i would like to expand my business to second factory , can i add a new facilities information on the available ISO ? or i have to apply a new ISO13485?

Medical Device Family

Dear 13485Academy, we develop a software as a medical device in Class 1. We are about to develop a new device which has many many similarities with our existing medical device. It uses the same basic structure, design, etc.. However, the characteristics of the users are different, as well as the intended purpose (only slightly, but still). Are we allowed to only have one Technical Documentation for both our products?

Auditing Biomedical service providers

I am the Regional Quality Director for Intl SOS in Africa. Lot's of our clients want to use service providers in Africa for servicing and calibration of Biomedical equipment. What are the minimum criteria I should ask for when auditing them?

Qualification of Bio-technicians?
Against which standard they are performing their calibrations? And btw, should this not be stipulated in the calibration certificates?
Against which standards are their measuring and calibration equipment calibrated/standardized?

This is but a few I can think of - can you please assist me with this as I want to create a procedure for verification of Service Providers for the region.

Masks effectiveness

Are all the masks produced under the mentioned standards effective against the COVID-19?

Standard for protective equipment

I try to download the standard for "Personal Protective Equipment" and Medical Device. I am not sure I found what standard the manufacturer might to comply with.
If we are wholesale and distributor, I also need to know how kind of certificate we have to request from our suppliers.

ISO 13485 N95 Face Mask

ISO 13485 implementation time frame

How much time would be needed to "adjust" the toolkit to a company? I know this is not an exact science, but maybe some comments
would help. I expect you to have quite a base of users to give you some idea. 

ISO 13485 and ISO 9001

I am in the process of implementing ISO 13485 using the templates from Advisera.  Our parent company is also implementing ISO 9001:2015 at the same time. The global procedures of 9001 seem to overlap with the global procedures of 13485 (i.e. Quality Policy, etc). My question is in regards to implementing both of these certifications simultaneously, while avoiding double work. Do you have any suggestions on what parts of ISO 13485 overlap with ISO 9001 and visa versa? What takes precedence?

Documents for distribution company

1. We are trying to determine which documents in your  'ISO 13485 & MDR Integrated Documentation Toolkit'  are required for a 'distribution company' distributing medical devices. Understanding this more clearly will help to us to secure funding to purchase.

2. For use of this pack for a 'distribution company', can you please update your 'ISO 13485 & MDR Integrated Documentation Toolkit' document with an additional column indicating which procedures would be needed. This will help to convince management on the necessity to purchase the pack"