When manufacturing a Medical Device, you are required to establish, implement and maintain a Quality Management System (QMS) that complies with applicable regulatory requirements (such as ISO 13485, 21CFR 820, and MDSAP related regulations).
This can be a challenging process, because your Quality System is not a set of independent documents but is indeed an ensemble of documented policies and procedures that define many interrelated processes, like design and development, production, change control, supplier management, corrective and preventive action (CAPA) and more.
After years of practice and thoughts, we developed an effective quality system that our QA experts will help you customize and implement in your organization, in order for you to have an effective QMS, that complies with the requirements and is continuously improved.
You already have a quality system? Our experts have the knowledge and experience in all processes and will support your system through all product life-cycle phases, including development, clinical trials, audits, and placing devices in the market.
You want to sell your device in Canada? The Medical Device Single Audit Program (MDSAP) is what you need. This program allows recognized Auditing Organizations (AOs) to conduct a single auditof your quality system to assess the compliance with the relevant regulation requirements of Canada and four other countries participate in the program: Australia, Brazil, Japan and US.
We have the expertise and the experience to assist your organization with supporting and managing all activities toward obtaining the MDSAP certification, including choosing the right Auditing Organization for you, the establishment of a comprehensive gap analysis of your QMS processes, the implementation of all requirements within the quality system, the training of your employees, and the performance of internal audits. We can also lead your MDSAP audit and help you face the Auditing Organization.
The production and quality systems of medical devices and IVD must be audited regularly, to verify compliance with the relevant regulatory requirements, ensure the patients and users safety and the product quality, and constantly improve processes within the company.
We have the expertise and experience to conduct internal audits of your quality system, design control, production aspects, and clinical files, for compliance with ISO 13485, the FDA QSR, the MDR 2017/745, the IVDR 2017/746, MDSAP requirements, and others.
We can also provide auditing services of contract manufacturers, subcontractors and/or suppliers, according to your needs and requirements.
We have to create a clear methodology to address and follow design control requirements during the development of new products, or when significant changes to existing products are implemented.
How hard can this be? Apparently not so easy, considering the different stages that must be distinguished from each other, the gates, the design reviews, the I/O Matrixes, etc., taking into consideration risk management processes and human factors engineering as well. And let’s not even go into how to verify design output meets design input requirements, or how validations are conducted to ensure design output meets user needs and intended uses.
We do know development teams are focused on the device, so we can assist in leading, training, overseeing, and guiding the teams to comply with the requirements so you do not need to work so hard when an audit is coming up.
Risk management process aims to identify potential risks and failures occurring throughout the device life cycle, evaluate and balance them against the benefits of the device, and to ensure that adequate actions are taken for preventing and/or reducing these risks as far as possible.
We can assist you to integrate risk processes into your design, to make sure you do not overlook important considerations and mitigations and make this process meaningful, and not just a paper exercise.
What is the UDI? This Unique Device Identifier (UDI) is a traceability tool, aimed at increasing patient safety and optimizing patient care by proposing tailored legislation by both the FDA and the European Commission (with exceptions).
Our QA/RA experts will assist you in assessing the impact of the UDI implementation on your QMS processes, help you choose a designated Issuing Entity/Agency , support you with managing the UDI System for your products, register in the UDI database (GUDID, EUDAMED) and support you with implementing all requirements allowing you to sell your device on the territories you chose.