QMS consultancy for IVDs
Looking for QMS consultancy to help you comply with the latest in vitro diagnostic (IVD) regulations? QbD’s notified body (NB) experts are here to help.
Don’t hesitate to contact us for more information about our QMS consultancy services.
What does QMS consultancy for IVDs entail?
According to ISO 13485: 2016 (the reference standard), IVD manufacturers are required to have a QMS in place.
This standard is recognized as a harmonized standard for in vitro diagnostic medical devices in support of Regulation (EU) 2017/746. It was published in the Official Journal of the European Union on January 6, 2022.
As a consequence, IVD manufacturers need to ensure that their IVD devices remain available to patients in the European Union by maintaining their CE marking.
Due to the new classification of IVD products, 80% of the market needs the involvement of a notified body according to the regulation, instead of 8% of the market according to the directive.
Do you need to obtain the required certificate (CE IVD or ISO 13485) from the certifying body or notified body to sell your products in the EU?
Our consultants have extensive NB experience. We offer QMS consultancy for legal manufacturers and other economic operators to meet the new requirements for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (applicable as from May 2022) and ISO 13485:2016 or other standards.
Why QbD Group?
QbD has years of experience with numerous QMS projects for IVD manufacturers and other economic operators.
We are happy to assist you with:
- QMS consultancy to comply with IVDR, ISO 13485, risk management ISO 14971, etc.
- gap analyses, internal and supplier audits, and training
- templates, procedures, and QMS implementation
Our QMS consulting services may include an assessment and/or implementation or update of your quality management system where we provide the required procedures and training.
Depending on your needs, this will be done by you, us, or both parties.
Every project is different, but our QMS experts usually start with a gap assessment or internal audit. In addition to the standard assessment, you can request extra consultancy for updating/implementing your QMS documents/preparing new documents.
In this case, it should be determined how the documentation will be shared and how progress will be monitored. The time involved in the additional consultancy should be determined on a case-by-case basis.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.