Quality Management Workshop Codex4SMES
Under the Codex4SMEs - the support programme for diagnostics manufacturers, Med-Di-Dia Limited is offering 2 FREE workshops for Diagnostics Manufacturers.
Find the details about - Online Training: Quality Management System (QMS) / ISO 13485:2016 Workshop
There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers whose devices will be re-classified (devices higher than Class A) due to the rules associated with these changes.
This workshop will include:
- What is device classification (list of devices and classification code)
- QMS function and ISO 13485:2016 impact
- What do clauses 4 to 8 mean within the scope of ISO 13485:2016 and how do they apply
- Internal Assessments and Notified Body relationships
In order to avail the benefit of this workshop, the companies need to be eligble under the following crieteria:
- Check your eligibility:
- Before you apply, read the full Business Growth Programme description
- Select only one of the two services provided by Med-Di-Dia you want to apply for by June 3rd, 2022.
After checking the eligibility, Companies should:
- Complete an application form and
- Submit your application and your de minimis self-declaration