ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#31
Richard,

Thanks for doing the leg work. I was planning to do a cross reference with the table in the Trautman text, but now that's not necessary. One question: was the table verified by anyone?

Kevin
 
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J

Jimmy Olson

#32
I've checked a good portion of it, but not every single item. It wouldn't be a bad idea to double check it though.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#33
I'll do it then. It may take a day as my schedule is...well, yucky to say the least. Perhaps today over a late lunch.

Kevin
 

lindal

Involved In Discussions
#34
thanks

Thank you all for your help. I don't know what I'd do without you all (probably continue to flounder around).
 
W

wrodnigg

#36
SilverHawk said:
I hope Mr Ed does not mind that his matrix is shared by all.
This document is alreday spread over the web, so I think this is not a problem at all.

Some remarks to this matrix:

The use of the DIS and FDIS in the column headings (and within the matrix) are typographical errors.
The content of the chart is from the final, approved versions of ISO 13485:2003 and ISO 9001:2000.

Ed you writes in his table, that he did not find the regulatory definitions for "active implantable medical device", "active medical device" and "advisory notice".
These definitions are taken from Article 1 of the the COUNCIL DIRECTIVE 90/385/EEC

The term "advisory notice" is originally defined in EN 46001 and also
referenced in the GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

I have checked this matrix, and I agree in the most points, but a some places in the comments I think the terms "QS Reg" and "Standard" are mixed up.

p.s.: there are also some typos in the ISO 13485:2003 Standard too (eg. in the comparison Comparison-Table Annex B Section 7.5.5 should read "Preservation of PRODUCT" (not property)
 
L

lisa1666

#37
13485

Hi all,

This is my first post. I'm a few days new to this site and am very happy to have found it. I've been given the regulatory responsibility for a start-up. We'll be integrating a class II med device. All pcb's, metal enclosures etc will be produced by sub-contractors. We don't design, this was contracted. What is the best approach for me to take for 13485 compliance/certification. We'll also need FDA 510K. I'd appreciate any advice.
 

DannyK

Trusted Information Resource
#38
Lisa,

The steps that I use with most of my clients are:

1. Get a copy of ISO 13485:2003 and perform a gap analysis to determine where the gaps are.

2. Create a project plan addressing all the gaps.

3. Document the system in a manual with several procedures ensuring that all requirements are being met. Get approval from process owners.

4. Train employees and implement the system.

5. Perform an Internal audit and address any corrective actions issued.

6. Perform a management review.

7. Perform an Internal Audit of the management review and internal audit process.

8. Send documentation to the registrar.

You should also speak to several registrars to get an idea of costs and the process.

I hope this helps.
 

Al Rosen

Staff member
Super Moderator
#39
lisa1666 said:
Hi all,

This is my first post. I'm a few days new to this site and am very happy to have found it. I've been given the regulatory responsibility for a start-up. We'll be integrating a class II med device. All pcb's, metal enclosures etc will be produced by sub-contractors. We don't design, this was contracted. What is the best approach for me to take for 13485 compliance/certification. We'll also need FDA 510K. I'd appreciate any advice.
Hi Lisa:

In addition to Danny's list, don't forget a cross reference to The FDA Regulations within your Quality System Manual. I believe They will do an inspection prior to issuing you 510K approval.
 
L

lisa1666

#40
I have a question regarding design. My company does not design/engineer, we are using a contract engineering firm for this. We purchased the rights to a device and needed some modifications, which included complete processor change, source code and the like. My company is outsourcing most operations. We will be performing the final integration/inspection though; does this make us responsible for the design functions? Do I need to include design in my ISO 13485 manual. I have taken an exclusion to it so far, though I have not been certified or even audited yet. I'm still in the process of writing it. Another question is will the FDA accept us using a 3rd party engineering firm for design? I'm a bit stuck here, any help you could offer will be greatly appreciated!
 
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