Quality Assurance

QMS Consulting ›

A robust Quality Management System (QMS) is essential for medical device manufacturers to ensure product quality, safety, and regulatory compliance.

Mock Audit for ISO 13485 ›

Ensuring compliance with ISO 13485, the international standard for quality management systems (QMS) specific to the medical device industry, is essential for manufacturers aiming to meet regulatory requirements and deliver high-quality, safe products.

Risk Management for Medical Devices According to ISO 14971 ›

Risk management is a fundamental process in the lifecycle of a medical device, aimed at ensuring the safety and efficacy of the device for patients and users. According to ISO 14971, the international standard for risk management of medical devices, manufacturers are required to establish, document, and maintain a risk management process throughout the entire lifecycle of the device.

Quality Assurance Support for Your Medical Device

The regulatory framework for medical devices includes standards that establish requirements for quality management systems applicable to every manufacturer. Although these requirements are universal, the implementation can vary depending on several factors, such as device type, risk classification, etc. Building and maintaining a quality management system (QMS) requires a comprehensive approach and can be challenging. An effective QMS fulfills regulatory requirements and ensures the development and production of safe and effective medical devices.

Quality assurance encompasses many elements, including manufacturing, supplier management, vigilance and complaints handling, risk management, and the activities of the person responsible for regulatory compliance (PRRC). These elements are crucial and must be adequately supported within the QMS.

What can we do for you?

Our experienced medical device team can support you with quality assurance services

  • Mock audit for ISO 13485
  • QMS consulting
  • Mock audit for MDSAP
  • Medical device manufacturing support
  • Medical device supplier support
  • Medical device vigilance and complaints handling
  • Risk management according to ISO 14971
  • PRRC
Metehan Agaca
Senior RA Manager

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Metehan Agaca
Senior RA Manager

Let's Connect

Talk to an expert