When should I implement the ISO 13485 Quality System?
As soon as you can! The requirements that ISO13485 places on your product and company can impact both product design and your business strategy, so you should implement the quality system as soon as possible. Full implementation of ISO 13485 and compliance audits need to be completed prior to product certification and launch. As they can take several months to complete, they should be carefully planned for.
How long does it take to get ISO 13485 accreditation?
ISO implementation can take from 3 to 6 months. However, this does not mean that you will be ready for an audit in 6 months. Before being audited you will have to generate some records to provide objective evidence that your quality system is implemented and effectively managed. We recommend that you perform at least one internal audit that covers the whole standard and at least one management review. You also need to consider that you may not be able to book an audit straight away – it may take months from the first day of application for a notified body to perform an audit.
I am using an external design company for my product who is certified ISO 13485. Does this mean I am compliant with ISO1485 requirements?
No. As a legal manufacturer of medical devices, you are responsible for implementing and maintaining the Quality Management System in compliance with ISO13485. In most jurisdictions, you will be required to present an ISO certificate before you can apply for regulatory clearance.
What does ‘legal manufacturer’ mean exactly?
The definition of a ‘manufacturer’ as per ISO 13485 is this: natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s).
In other words – If you are planning to sell your newly developed medical device under your own name, you are considered a legal manufacturer and your contact details must be present on the device labeling.
I am looking to outsource my manufacturing activities. Is there a requirement for a contract manufacturer to be accredited ISO 13485?
There is no written requirement for contract manufacturers to be accredited. However, we would highly recommend you choose an accredited manufacturer. Regulators consider contract manufacturers to be critical suppliers, and therefore there will be an expectation on you to include an ISO certificate as one of your evaluation criteria. As a contract manufacturer performs all the manufacturing tasks on your behalf, it will be very challenging to demonstrate control of the manufacturing without implementing the quality system on site.
My contract manufacturer accredited ISO 9001. Is this enough to comply with medical device regulations?
No, there are significant differences between the standards and ISO 13485 is necessary to be compliant. Whilst ISO 9001:2008 (now superseded by ISO 9001:2015) forms the basis for ISO 13485, it is a standalone standard.
I received ISO 13485 accreditation, does it mean I can now market my device?
No. ISO accreditation does not mean automatic regulatory clearance for your product, it simply means you have a compliant Quality Management System, which is the first step in getting regulatory clearance for the device. Various jurisdictions have different processes for regulatory clearance for medical devices, for example:
- In the USA – you will have to apply for 510K / PMA
- In the EU – you will have to apply for CE mark with a designated notified body
- In AU – you will have to register your device with TGA (ARTG record)