Quality Management System for medical devices/in vitro diagnostics (DM/IVD)

The Quality Management System (QMS) is a control system, i.e. a set of activities aimed at verifying that the outcomes of the business processes meet the determined expectations. A QMS organisation is based on the documents defining the activities carried out by the company to ensure quality.

What is ISO 13485?

The UNI CEI EN ISO 13485 norm is a technical standard for QMSs specifically designed for companies dealing with design, manufacturing, storage and distribution of medical devices/in vitro diagnostics (DM/IVD).

The ISO 13485 certification shows that an organisation successfully meets this standard’s requirements.

Who is it for?

From product design to distribution, through manufacturing and installation, all companies in the field can implement a quality management system based on the ISO 13485 standard.

Is it mandatory to have a QMS?

Regulation EU 2017/745 (on MDs) as well as Regulation EU 2017/746 (on IVDs) provide for that all manufacturers, authorised representatives, importers and distributors have a QMS inside their organisation allowing the management of products and processes in accordance to the regulations’ requirements.

Is it mandatory to certify the QMS according to the ISO 13485 standard?

No, it is not mandatory to have an ISO 13485 certified QMS, however a QMS organised according to the requirements of this standard is considered one of the pillars for the compliance with the requirements needed to obtain the CE marking for one’s medical device/IVD.

What is the CE marking?

The CE marking is a certification of conformity that is released to specific categories of products if they are considered to comply with the requirements provided for by the EU on safety, health and environmental protection.

Of course, these categories also include MDs/IVDs, with the goal of ensuring more safety and facilitate their free circulation in the European common market.

How can the ISO 13485 certification be obtained?

The procedures to obtain the ISO 13485 certification are quite challenging. A valid possibility is to refer to expert consultants.

With its 40-year long experience, Di Renzo Regulatory Affairs can assist you in the implementation of the Quality System for Medical Devices and In Vitro Diagnostics, in compliance with the requirements established by the regulations, providing full assistance.

Di Renzo Regulatory Affairs has a highly qualified staff dedicated to the quality management services, and can assist companies in the following activities:

Advice for the setup and maintenance of a Quality Management System according to ISO 13485 standard
gap-analysis for the control of the Quality Management System
drafting of a Quality Manual
drafting of Standard Operating Procedures (SOPs)
setup of the data recording system
assumption of the role of Quality Assurance for ISO 13485 systems
audits on the Quality Management System of manufacturers and/or distributors
pre- and post-inspection audits by Notified Bodies and competent Authorities at manufacturers and manufacturing sites of medical devices
audits at suppliers of manufacturers of medical devices to assess the level of conformity with the ISO 13485
assistance in the management of non conformities and corrective and preventive actions (CAPAs)
participation to meetings to review the executive management and/or support in the drafting of the meeting minutes (Management Review)
in-house training on the QMS and on the general principles of specific ISO norms
management of complaints and post-marketing surveillance procedures
control and update of the QMS documentation