Hello,
I am an experienced med device manufacturer/PM, who is working on a startup med device man company. My task is to create a quality system and implement a small cleanroom. We want to manufacture and package class II devices in small quantities. My questions are:
1. I know I need to establish a Design Control system. Any advice on where to obtain a template/example systems?
2. As for our manufacturing site, what guidance tells me ISO certifications are required? Is that part of the CE mark/510k process?
3. Do I have to perform the manufacturing in a clean room or a controlled environment?

I know these are very broad questions, but I just need to know where to start looking for answers. I don't want to go to an unknown consultant who is going to overcharge me too much for too little info...I need to arm myself with information before proceeding...Thanks for any advice!

<snip>I don't want to go to a consultant who is going to charge me too much for too little info.

Potato,

Welcome to The Cove Forums! :bigwave::bigwave:

I am sure that someone will respond to your post.

However, please be advised that some of us here at The Cove Forums are consultants who help many folks with a lot of good information at no charge!

Stijloor.

Welcome to The Cove! :bigwave:

This article is pretty old, but still has a lot of guidance to get you started: Building the Right Cleanroom Environment (http://www.devicelink.com/mddi/archive/96/02/014.html)

Here's a book titled Cleanroom Design (http://www3.interscience.wiley.com/cgi-bin/bookhome/93516511/).

This site has a Search function - see the tool bar with yellow font. Also, when looking up a subject check out the related links section at the bottom of the page.

I hope this helps!

Hello,
I am an experienced med device manufacturer/PM, who is working on a startup med device man company. My task is to create a quality system and implement a small cleanroom. We want to manufacture and package class II devices in small quantities. My questions are:
1. I know I need to establish a Design Control system. Any advice on where to obtain a template/example systems?
2. As for our manufacturing site, what guidance tells me ISO certifications are required? Is that part of the CE mark/510k process?
3. Do I have to perform the manufacturing in a clean room or a controlled environment?

I know these are very broad questions, but I just need to know where to start looking for answers. I don't want to go to an unknown consultant who is going to overcharge me too much for too little info...I need to arm myself with information before proceeding...Thanks for any advice!

Two animals, possibly three, you have to deal with:


FDA, for certain - if you make a medical device in the USA, you need to CYA with them. I won't go into detail here - almost everything you need to know is on the FDA website.
ISO 13485 - (if you intend to sell/distribute in foreign markets) most foreign governments, including Canada, have agreed to a harmonized process of approval based on the manufacturer being registered to ISO 13485 - careful here - only a few registrars are "approved" by these governments to issue such registration.
CE mark - this can be easy or difficult, depending on your product - we'll need more specifics from you before we tackle this topic. It is separate from ISO and FDA.

Clean room requirements depend on the product and how it is used with the patient. I am aware of at least one medical device manufacturer (one of my clients [disclosure]) that has ALL the approvals (FDA, ISO 13485, CE) and essentially farms out sterilization AFTER manufacturing since its product does NOT require clean room conditions in manufacture.

:topic:If you have an interesting enough situation, I might be interested in it as a case study - see
Wes Bucey offers service as "Strategy Advisor" - Seeking Case Studies for Book
(http://elsmar.com/Forums/showthread.php?t=9117)

Wes and Jennifer,

Thanks to both of you for the information, it is much appreciated!

#2: To get started for the ISO cert, how is it best to proceed? Let's say that I have QSRs that are generic, but ok. And I have a cleanroom built, validated by my procedures. Do I just buy the ISO document and start on page 1? What is the process?

I have experiences with preparing 510ks and data for CE mark, but not developing the systems to do so, that is where I am stuck.

However, I think the cleanroom information will get me started in that direction, and any info on ISO cert path-of-least-resistance would be appreciated as well.

Here's a clean room trade magazine which might interest you - I have no connection other than being a subscriber.
http://cr.pennnet.com/ (http://www.omeda.com/cgi-win/clnrms.cgi#)

Wes and Jennifer,

Thanks to both of you for the information, it is much appreciated!

#2: To get started for the ISO cert, how is it best to proceed? Let's say that I have QSRs that are generic, but ok. And I have a cleanroom built, validated by my procedures. Do I just buy the ISO document and start on page 1? What is the process?

ISO 13485 is an extension of 9001, You will need a quality management system (QMS) in place based upon the requirements of both 9001 & 13485. Although relatively simple, mapping your processes & documenting your quality systems can be a significant task.

The QSRs referred to - are they the inspection instructions or quality system documents? (I have seen both documents referred to as QSRs).

By QSRs I meant a QMS system(my old company referred to them as QSRs). I have a generic one that I am building, it came from an ASQ lecture. However, if anyone knows of others, please let me know...