ISO 13485 - Overwhelmed by various Medical Device standards

L

Limmeng

#1
Hi.

I am overwhelmed by a lot of other standards related to ISO 13485.

I am helping a friend, whose boss is asking to conduct preliminary studies. The information that he has:

1. It is a passive device and also include stretcher. Do all device need to go through sterilization process?

2. What is the relationship between ISO 13485 with CE Marking and FDA?

3. As it is at the infant stage (proposal), the company does not have specific country to esport the product. So, which "other standards" are advisable?

4. If it is to be exported to the US, then which regulaton should the company prepare to comply?

Thank you,
Lim
 
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M

MIREGMGR

#2
Re: ISO 13485 - Overwhelmed by various standards

Do all device need to go through sterilization process?
Generally, all devices that directly or indirectly may contact any aspect of a patient greater than unbroken skin for a brief time must be sterilized and must have acceptable residuals and/or pyrogenicity, and must be biocompatible.

What is the relationship between ISO 13485 with CE Marking and FDA?
Medical device companies with quality systems are better able to consistently produce safe and effective products. ISO 13485 defines a quality system. The FDA's quality system is variously called the QSR and the GMPs. Other countries may require or expect one or the other of these, or may have their own unique approach.

CE Marking, and more generally, compliance with the Medical Device Directive (and if applicable the Machinery Directive, Personal Protection Equipment Directive or others), is a system for communicating to users that a product meets appropriate standards and requirements. The FDA also has product requirements; rather than using a mark, the FDA system is comprehensive, i.e. if a medical device is available in the US, its FDA compliance is inferred because it is legally mandatory. The FDA reviews qualifications of all but the lowest risk products, and their qualification may be checked against an online database. As with quality systems, other countries may use one of these approaches, or have their own.

which "other standards" are advisable?
That's an extremely open-ended question, as there are many standards, either directly applicable to products, or applicable to materials and processes. Your product type determines what applies.

In my experience working for a maker of sterile disposables, fluid handling products, radiation shielding systems and patient support/positioning systems, the most commonly applicable standards are ISO 14971 (risk management), the ISO 10993 family (biocompatibility), ISO 11135 (EtO sterilization), ISO 11607 (sterile barrier packaging), the IEC 60601 family (medical electrical systems), IEC 62366 (usability), AAMI PB70 and ISO 13795 (performance of drapes and covers), and ISO 14155 (clinical trials).

If it is to be exported to the US, then which regulaton should the company prepare to comply?
Medical device makers intending to sell into the US must be registered with the FDA, and their products must meet FDA requirements.

My suggestion would be that before this project goes forward, the company involved might want to bring in someone...an employee or a consultant...who has a high level of familiarity with the issues involved and can move beyond these basic questions to the necessary details and actions.
 
L

Limmeng

#3
Dear MIREGMGR,

Thank you for such informative reply. I believe a lot of things need to be studied.
And more importantly, the 'structure' is now clearly understood. Thank you again.
 
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