Medical Device QA

Ensuring Quality and Compliance for Medical Devices

At Key2Compliance, we understand the critical role medical devices play in healthcare. We are dedicated to supporting manufacturers in delivering safe, effective, and compliant products to the market. Our approach is tailored to each client’s unique needs, ensuring a personalized and efficient service. 

Contact us to learn more about our services and how we can assist you in your journey towards quality and compliance excellence or just good enough. 

Medical Device Quality Assurance

We know the requirements - and ensure you meet them

Our medical device QA services offer comprehensive solutions that include regulatory compliance consulting, quality system implementation, PRRC, and auditing. Our team is experienced in handling various types of medical devices and is well-versed in international regulatory standards.

Regulatory Compliance

Compliance with regulatory requirements is of utmost importance. Our QA/RA consultants can help navigate the complex landscape of regulations, such as Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Quality System Regulation (USA) ensuring that all necessary standards are met at an appropriate level.

Validation and Verification

Validating and verifying the performance and safety of medical devices is crucial. Our QA/RA consultants provide guidance on conducting appropriate validation and verification activities, including design verification, software validation, and process validation.

Quality Management Systems (QMS)

A robust QMS is essential for maintaining consistent quality throughout the device’s life cycle. Our QA/RA consultants assist in implementing and optimizing QMS processes, for example including document control, risk management, CAPA, and change management.

Read more →  

Person Responsible for Regulatory Compliance (PRRC)

In EU all Manufacturers and Authorized representatives need a PRRC. This is a personal responsibility with certain requirements on training and experience. Our QA/RA consultants can take the role of PRRC at companies with less than 50 employees

Quality Manager or QA

A Quality manager or QA is a function that makes sure that companies keep the regulatory compliance and QMS up to date. They also make sure that quality activities are planned and performed. Our QA/RA consultants can take the function of Quality Manager or QA at our customers, the extent is up to you.

Auditing and Inspection Readiness

Being prepared for regulatory audits and inspections is necessary to maintain compliance. Our quality assurance consultants help conduct internal audits, prepare for external audits, and provide guidance to ensure inspection readiness, including proper documentation and adherence to regulatory requirements.

Want to learn more about the road to CE-mark for your medical device?

The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.

In this guide, you will find:

  • Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
  • Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
  • Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
  • Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.
 

Download our guide and start your road to CE mark!

IVDR Compliance made simple

Simplify your path to In Vitro Diagnostic Regulation (IVDR) compliance. Let us guide you through the complexities of IVDR implementation, ensuring a seamless and successful compliance experience. Don’t navigate the regulatory landscape alone – Rely on us

Simplifying your journey to MDR Compliance

Navigate the complexities of the Medical Device Regulation (MDR). With our guidance, we streamline MDR compliance with thorough gap assessments, technical documentation review, and clinical evaluation support. We help you develop a robust post-market surveillance strategy and optimize your QMS to align with MDR requirements. Our customized training programs empower your team with the knowledge and skills for MDR compliance.

Fulfill USA market regulations with QSR compliance

Simplify your entry into the USA market with our expert guidance. We will assist you in navigating the intricate FDA requirements, ensuring a seamless and successful compliance experience. Count on our support and expertise, so you don’t have to navigate the regulatory landscape alone. 

US-Map

MDSAP Compliance made simple

Get your Quality Management System (QMS) ready for a MDSAP (Medical Device Single Audit Program) audit with our assistance. We will conduct a thorough GAP analysis, make necessary updates, and conduct a Mock audit.

Rely on us - meet our experts

“With an experienced team and extensive knowledge, Key2Compliance provides comprehensive quality assurance services for medical device manufacturers. We support roles like Quality Manager, QA/RA, and PRRC, conduct GAP analyses, audits, and assist during Notified Body audits, ensuring robust quality management systems and audit readiness.”

Åsa Möllby, Director Of Quality Assurance

Åsa Möllby

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