Quality Management System (QMS)
Our dedicated experts can help you design, implement, and manage your QMS so that it supports your organization’s processes and meets applicable regulations and standards.
QMS services for the medical device industry
The implementation of the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have enhanced the requirements for the safety, quality, and performance of medical devices and in vitro diagnostics within the European Union. In the US the Quality System Regulation (QSR) part 820, recently updated to Quality Management System Regulation (QSMR), serves the same purpose.
These regulations aim to improve patient safety, ensure the reliability of medical devices, and strengthen regulatory oversight throughout the lifecycle of these products, from design and manufacturing to post market surveillance. These regulations set out the requirements for a quality management system specific to the medical devices industry, e.g. ISO 13485. The manufacturer is therefore expected to demonstrate that their quality management processes are compliant and efficient in order to fully support the organization. This includes any software used in the QMS or manufacturing.
If you need support or training in computer system validation of software used in manufacturing or within your quality management system, contact us for more information. We have proven experience in planning, execution, evaluation, and documentation in the performance of computer system validation. Our reference material is GAMP V or AAMI TIR 36, ISO/TR 80002-2 depending on your needs.
Examples of other services we provide:
- Planning and designing the quality management system to support the organization’s processes and meet applicable regulations and standards, such as ISO 13485, MDR, IVDR, 21CFR820, etc.
- Inclusion of other relevant standards such as ISO 14971, IEC 62304,
ISO 62366-1, etc. - Designing and implementing electronic quality management systems (eQMS)
- Gap analysis and roll-out plans for QMS changes
- Conducting audits
- Interim QA and RA managers
- Acting PRRC (Person Responsible for Regulatory Compliance)
- Training sessions and materials (custom or open training)
Get in touch with us
Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.