A quality system for people in the Medical Device industry

A quality management system forms a good foundation and understanding of the demands within the medical technology industry.

The quality management system is the practical application in the organisation that ensures it complies with regulations. The purpose is for companies to provide safe and effective products in the market.

Building an effective management system with sustainable processes means companies are able to be successful. A management system simply describes how you should go about developing medical technical products and how you run your business in the most streamlined way. The quality management system therefore deals with the practical work that is performed every day, as well as structure, communication and collaboration.

By implementing a quality management system in accordance with the standard, the relevant parts of the MDR/IVDR regulations are complied with.

As a consequence of the new regulations, the requirements for quality management systems have increased significantly, particularly for Class I products.

The quality system complies with:

ISO 13485:2016
ISO 14971:2019

Regulatory – MDR 2017/745

SOP – Regulatory Compliance
SOP – Post Market Surveillance (Kommer sen)
FORM – Regulatory Strategy for Device (or Device Family)
FORM – Safety and Performance Checklist (Annex I)
FORM – General Product Description (parts of Annex II)
FORM – Qualification & Classification of Medical Devices (MDR, Annex VIII)
FORM – Qualification of MD software
FORM – Checklist Technical Documentation (Annex II)
FORM – Summary Technical Documentation (Annex II)
FORM – Post Market Surveillance Plan (Kommer sen)
Record – Example of content of Instruction for Use (IFU)
Record – Example of content of Label Specification

Regulatory IVDR 2017/746

SOP – Regulatory Compliance
SOP – Post Market Surveillance
FORM – Regulatory Strategy for Device (or Device Family)
FORM – Safety and Performance Checklist (Annex I)
FORM – General Product Description (parts of Annex II)
FORM – Qualification & Classification of Medical Devices (MDR, Annex VIII)
FORM – Qualification of IVD software
FORM – Checklist Technical Documentation (Annex II)
FORM – Summary Technical Documentation (Annex II)
FORM – Post Market Surveillance Plan
Record – Example of content of Instruction for Use (IFU)
Record – Example of content of Label Specification

General

SOP – Computerized Software Validation
FORM – Risk Analysis for Computerized IT system
Record – Master Validation List – computerized Software

Management Responsibility

SOP – Quality Manual
Record – Example of Quality Policy
Record – Example of Quality Obectives, Quality planning
SOP – Management Control
SOP – Change Management
FORM – Change Request (CR)
SOP – Management Review
FORM – Management Review Agenda/protocol
SOP – Communication Internal & External
SOP – eQMS Process, risk based approach
Record – Example of Risk Analysis for QMS processes
SOP – Functions, Roles and Job Descriptions
Record – Example of Organisation chart

Document Management

SOP – Document Control
SOP – List of External Controlled Documents
SOP – Translation
SOP – Archiving
SOP – Product related information material
WI – Review and approval Matrix

FORM – SOP for eQMS

Resource Management
SOP – Resource Management
SOP – Competence and Training
FORM – Training record
FORM – Personnel CV upload
FORM – Introduction Program
FORM – Performance and Development Review

MedQtech is a consulting company that started in 2016. They provide practical support to customers in regulatory matters, both for medical devices and diagnostics. The team at MedQtech all have previous experience from work with medical technology products and they have – together with other partners – broad competence to support customers in most matters. This includes helping customers to implement quality systems in accordance with ISO 13485 and QSR 21 CFR part 820. In addition, they support several customers’ development projects by, for example, compiling the technical documentation required under the relevant regulations (MDR/IVDR).

MedQtech is proud to offer – together with AM System – a digital quality management service, which streamlines the work of complying with regulations and makes it possible to support customers throughout Europe.