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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics PRRC under MDR or IVDR Checklists >>
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

Quality Management System for Medical Device Companies

A well-structured Quality Management System stands as one of the most critical elements in the journey towards CE certification. A robust QMS serves as the foundation upon which successful audits and regulatory approvals are built.

Quality Management System for Medical Device Companies

A well-structured Quality Management System stands as one of the most critical elements in the journey towards CE certification. A robust QMS serves as the foundation upon which successful audits and regulatory approvals are built.

Core elements of a Quality Management System

Risk Management The QMS should include risk mana- gement processes that identify, assess, and mitigate risks associated with the design, manufacturing, and use of medical devices. Risk analysis is critical to ensuring patient safety and regulatory compliance. Design and Development Controls For companies involved in designing medical devices, the QMS should incorporate design and develop- ment controls to manage product design activities, verification, validation, and design changes. Quality Policy and Objectives The company should define a clear quality policy that outlines its commit- ment to meeting customer needs, regulatory requirements, and conti- nuous improvement. The quality objectives, based on the policy, set measurable targets for the QMS's effectiveness. Document Control A robust document control system ensures that all relevant documents, including policies, procedures, work instructions, and forms, are well-managed, reviewed, approved, and up-to-date. Supplier Management An effective QMS includes processes for evaluating, selecting, and monitoring suppliers to ensure that purchased components, erials, and services meet quality standard. Production and Process Controls Procedures should be place to ensure that manufacturing processes are well-controlled, vali- dated , and consistently produce devices that meet specifications. Corrective and Preventive Actions (CAPA) The QMS should include a a CAPA process to address and resolve nonconformi- ties, customer complaints, and potential issues to prevent recurrence and improve overall quality. Training and Competence Employees involved in the design, manufacturing, and quality control of medical devices should receive appropriate training to perform their roles competently. Internal Audits Regular internal audits assess the effectiveness of the QMS, identify areas for improvement, and ensure compliance with established procedures and regulations. Management Review Top management should peri- odically review the QMS to evaluate its suitability, adequacy, and effectiveness, making data-driven decisions for continual improvement. Post-Market Surveillance Companies must establish processes for monitoring and collecting feed- back on the performance of medical devices after they are released to the market, including gathering data on complaints, adverse events, and product performance. Traceability and Docu- mentation CE-marking requires comprehensive and well-documented technical documentation, including design specifications, risk assessments, clinical data, and post-market surveillance.

Creating an MDR and ISO 13485 compliant quality system


ISO 13485 compliance holds immense importance for medical device companies aiming to deliver safe and effective products to the market. This international standard outlines specific requirements for a Quality Management Systems of medical device companies.


We will work closely with your company to tailor a quality management system that aligns with the specific needs of your medical devices and business operations.

Contact us today to explore how we can empower your company with effective QMS solutions, laying the foundation for MDR compliant operations.

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Email: info@mdrc-services.com
 

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EU Authorised Representative (EC REP)

PRRC

Technical documentation

Risk management

Clinical evaluation

Notified bodies

Quality management system

Post-market surveillance system

Your products

Medical devices and medical equipment

In vitro diagnostic medical devices

Medical software

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

UDI infographic

EUDAMED registration step by step instruction

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>


Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

Read more >>


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Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.