Quality
At Congenius, we offer in-depth knowledge and broad experience across a wide spectrum of medical and In-Vitro Diagnostics (IVD) devices, that enables the optimisation of your quality related processes to meet the relevant regulations and standards. Whether your challenge is in quality management, quality engineering or quality assurance, our highly skilled Quality team can help you achieve the smartest solution.
Be it support with process implementation or operational assistance, we aim to complement the skills of your internal team with tailored resource, whilst helping to drive your business forward by offering strategic thinking and leadership. We enable risk-based decision making in processes and daily operations, and facilitate cultural change towards compliance and quality, encompassing the various functions within your business.
Regardless of the size of your requirement or the nature of your challenge, our goal is to empower you to grow and develop your business sustainably. Read more about our services below.
Quality Management
Quality Management ISO 13485 / 21CFR820
The creation of a quality management system (QMS) that adheres to EN ISO 13485 (CE), and the QMS requirements from MDR or IVDR and / or FDA 21CFR820 (US) and / or MDSAP is fundamental for compliant product development and marketing.
Based on these specifications, we can define the processes necessary for your individual company, or improve your existing processes to achieve heightened efficiency and effectiveness. If required, we can also support you operationally in the execution of these processes.
A certified management system not only forms the basis for successful product certification, but also creates transparency, and encourages acceptance of your various corporate processes. Importantly, it also serves to significantly reduce room for error.
Mock Auditing & Internal Audits
Our Quality consultants can help you prepare for a successful audit.
Our Mock-Auditing service examines whether your quality management system is ready for an audit by a notified body or a regulatory authority. We would be happy to provide you with a mock-audit tailored to your specific needs. Similarly, should it be required, we can also support you with the execution of Internal Audits.
Supplier & Distributor Quality
To ensure suppliers are effectively managed and regulated, control measures need to be determined through a risk-based approach.
We can support you with the establishment and implementation of the necessary control measures including quality agreements, supplier auditing, an effective SCAR process, supplier development activities and supplier issue resolution.
Similarly, activities of distributors may have to be regulated via quality agreements and audits, as required especially by MDR and IVDR. We can help you to establish and implement a risk-based process to fulfil these requirements as well.
Quality Assurance (Design related)
Risk Management ISO 14971
Performing product risk management is a central component of compliant product development and marketing.
We can support you with; setting up a risk management process in accordance with ISO 14971, creating a product risk management file, and moderating the implementation of FMEA`s. We can also help you to maintain your product risk management files in an efficient way throughout the lifetime of your products. Our expertise in this area will help you stay in control of your potential product risks.
Usability Engineering IEC 62366
Usability engineering defines the requirements of the user-device interface by assessing effectiveness, efficiency, user friendliness and the resulting satisfaction of the user.
The focus of IEC 62366 is twofold: to minimise the risk of poor usability and to define a development process for usability. Our Usability experts can help you install a development process that adheres to this standard, supporting you by demonstrating the correct use and implementation of usability engineering for your device throughout its lifetime.
Software Life Cycle IEC 62304
Any stand-alone software that is classified as a medical device, or software that is part of a medical device must meet the requirements of IEC 62304.
This standard sets out the minimum requirements for the most important software lifecycle processes including: software development, software maintenance, software risk management and software configuration management. We can help you to build a software lifecycle process in accordance with this standard, as well as guiding you through the correct application and implementation of this process for your individual product.
Electrical Safety IEC 60601
If your medical device is electrically operated or integrates software, the requirements of IEC 60601-1 must be met.
We would be happy to advise you on the correct interpretation of this comprehensive standard, and use it to define the requirements for your device. Together, we can ensure that the possible risks in connection with your device electronics or device software are either correctly addressed and excluded at the start of development, or minimised through design measures during the design development phase.
Design Verification & Validation
It is essential to proof fulfilment of requirements and specifications for medical and IVD devices.
Our team of experienced consultants can support you in planning and executing product verification. Additionally, we offer support with product validation through clinical and usability studies and their downstream evaluation.
Find out more about our services covering Equipment & Infrastructure Qualification, Process Validation and Test Method Validation on our Operations page.
Quality Engineering
Before distributing your manufactured product into the market, you need to define the quality criteria to be monitored during the product’s market phase.
Post-market, it is inevitable that you will identify areas to improve regarding the product itself or the manufacturing processes. Our Quality engineers can support you in finding the right solutions to achieve this improvement, either pre-market in quality planning, post-market with root cause analysis, or in the framework of the CAPA or complaint processes.
For information on how we can help you with Quality Control and Control Strategy specifically for your manufacturing process, see our Operations page.
Labelling & Packaging
Medical technology products must be able to maintain their performance and safety standards throughout transportation and storage.
It is therefore vital that product packaging requirements are included in the development process and proven via packaging and shipping validation.
Alongside this, is the importance of clear and accurate labelling and easily interpreted user instructions. Label material and the labelling process itself must be safe to ensure that products are correctly labelled, and labels are legible during the lifetime of the product.
Our Labelling and Packaging consultants have the necessary expertise to help you create and operate an effective process in these areas, so that your product is delivered to the end user in perfect working order.
Quality Transformation
Quality Transformation (including Change Management)
A healthy Quality Culture is crucial for the overall success of a medical device organisation.
However, in reality we often find that the Quality Culture within a company falls short, frequently focused on formal compliance but not supportive of the organisation’s other needs – therefore missing an opportunity to bring added value to the company.
By applying our proven approach, which balances evolution to engage stakeholders (i.e., organisational development), and revolution to create disruption (i.e., change management), we can help companies to accelerate their “Quality Transformation” – transforming the organisation’s culture, mindset, and processes.
You can find out more about Quality Transformation in our whitepaper.
Leadership
Interim Leadership
Within our Quality team, we have senior consultants who are able to lead any quality group or department on any level within your company ad interim.
With robust experience in leadership roles, we can enable your team to reach their specified goals and if needed, develop your team according to your company’s requirements.
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