QMS consultancy
Looking for QMS consultancy to help you comply with the latest 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.
Part of QbD Group
This service is supported by Qarad
What does QMS consultancy entail?
According to ISO 13485: 2016 (the reference standard), 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, MD and IVD manufacturers need to ensure that their devices remain available to patients in the European Union by maintaining their CE marking.
Do you need to obtain the required certificate (CE 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 MD and IVD manufacturers and other economic operators.
We are happy to assist you with:
- QMS consultancy to comply with MDR, 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.
Project approach
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.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
