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.
Our Quality Services
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.
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.
Biocompatibility ISO 10993
A structured procedure for biological assessment which follows ISO 10993 is crucial for the selection and evaluation of any materials to be used on or in the human body.
We can assist with the correct interpretation of this standard and utilise it effectively to define the requirements for your specific device. This facilitates the systematic assessment of the biological hazards of proposed materials at the start of product development: saving time and money, and ensuring lasting patient safety.
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.
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.
Processing: Cleaning, Disinfection & Sterilisation ISO 17664
ISO 17664 specifies the requirements for the information to be provided regarding the processing of a medical device that needs cleaning, disinfection and / or sterilisation to ensure the device is safe and effective for its intended use.
Our experienced Quality team can help you interpret this standard, and define what is appropriate and essential for your device development.
If your device is sterile, we can also support you in the implementation and application of the regulatory requirements for individual sterilisation methods and sterile medical devices including; upstream cleaning, primary packaging of sterile products and sterile barriers.
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.
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.
Verification & Validation
It is essential to proof fulfilment of requirements and specifications for medical and IVD devices, as well as for processes used to manufacture and test your devices.
Our team of experienced consultants can support you in planning and executing product verification, including infrastructure and equipment qualification and process and test method validation. Additionally, we offer support with product validation through clinical and usability studies and their downstream evaluation.
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.
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.
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.
– Co-Founder & CEO
“I found their creative but simple solutions for addressing non-conformity extremely helpful. There was no unnecessary work undertaken – just the provision of straight forward and proactive solutions. I needed matter of fact input; advice and tools that were lean and to the point. And that is exactly what I received. As a result, my understanding is now increased, and compliance has been achieved.”
“Working with Congenius was straight forward, helpful and efficient. As well as being very knowledgeable, they introduced us to useful tools that made our working lives a lot easier. Their positive attitude and uncomplicated ways of working kept things easy. Our collaboration allowed us to define our procedures and to improve efficiency and productivity, whilst finding pragmatic ways to ensure only the necessary work was completed.”
– Product Management
“Jörg helped us to lay the groundwork for our documentation and organisational structure. Being quality driven and business savvy, he was a reliable source for knowledge and understanding – we always received clear explanations, and I don`t recall a single question he couldn`t answer! His patience and ability to apply give and take helped us to progress in a way that suited our business, and with his methodical and thorough approach he became a driving force toward delivery. Our partnership improved our company`s efficiency and quality – it was the best investment we made last year.”
Co-Founder & Medical Director
“Jörg has supported us in the process of getting our medical products approved. His experience, honesty and reflective thinking helped us to guide us effectively through the process. Jörg’s authentic commitment to customer service has helped to strengthen our working relationship. We see him as a true partner and will continue to work with Congenius.”
News & Knowledge
Creativity meets philanthropy – A film that will improve the lives of children in India
At Congenius, we are committed to facilitating healthier lives, be that through our consultancy work in medical devices, or via…
MedTech news round up November
As part of our goal to keep our customers informed and up to date, we will now be regularly publishing…
Launching Congenius 2.0
After four years of successful business growth, the time had come to take Congenius to the next level. To help…
Consultant Spotlight – Carina Rembeck
Introducing our Consultant Spotlights… Our team at Congenius share important commonalities; MedTech expertise, a thirst for knowledge and a love…
A guide to De Novo registration
At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six…
Subscribe to our monthly knowledge update