Our detailed understanding of the highly regulated medical devices and combination products environment allows us to offer reliable support to customers who need to optimise their operational processes.
With our breadth of knowledge and adaptable skillset, we enable effective solutions whilst operating within the established boundaries of each project. We understand the importance of achieving time and cost efficiencies, so we immerse ourselves within your business quickly, and draw upon proven approaches to achieve lean and proficient processes.
With competition increasing in our evolving industry, it is more important than ever to achieve lasting solutions. So every answer, decision or piece of advice we provide, aims to facilitate long-term success for our customers. Take a look at our service portfolio below.
Quality Assurance (Production related)
Robust and reliable processes are the basis of good manufacturing practice for pharmaceutical products or medical devices.
Our Process Engineers are well-versed in the current good manufacturing practices (cGMP) which serves to achieve the most effective results. Whether your project requires a Lean approach, Kaizen application, or the utilisation of Six Sigma, our Process Engineers apply the right selection of tools and methodologies to fit the individual challenges within your quality management system.
Biocompatibility, Sterility & Product Cleanliness
A structured procedure for biological assessment which follows ISO 10993 forms a vital part of an effective manufacturing process.
Our Biocompatibility experts can help to fulfil this standard for your devices, by supporting with early stage evaluations, or remediation activity for an existing product portfolio. By systematically assessing the biological hazards of proposed materials either at the start of product development, or for existing products, our aim is to save you time and money, and to ensure lasting patient safety.
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 sterility expert 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.
Equipment & Infrastructure Qualification
The use of equipment or infrastructures that have a direct or indirect influence on product performance or product safety must be qualified in advance before use.
We can support you in the development and execution of the qualification process to help ensure your medical devices are manufactured with qualified equipment and infrastructure.
Our Process Validation experts know how to efficiently fulfil the appropriate GMP rules and requirements to ensure the acceptance of the capability of your manufacturing processes.
We can help you to set up and execute efficient, stable, and risk-based validation processes to support in this area.
Test Method Validation
Inspection & test equipment is the focal point of every inspection or audit, and equipment control goes beyond the standard calibration process.
We can support you in this area by defining and executing test method validation including measurement systems analysis (MSA) to ensure your products are tested to consistent standards. This will provide you with robust and reliable data from which to develop your product as required on the journey to device registration and commercialisation.
Quality Control & Control Strategy
By providing tailored support at every step along the production process, our Quality Control experts can help you to guarantee that all products are manufactured, assembled, and inspected according to the relevant standards along the entire product life cycle.
As a result, your finished product will be safe, reliable, and compliant.
For more information regarding our general Quality Engineering services, see our Quality page.
– 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.”
Johannes G. Bremmers
Vice President Quality Assurance & Regulatory Affairs
“Jörg and his team have helped us to address several challenges from improving our quality system to re-engineering and validating manufacturing processes and implementing software tools. In these projects Congenius has demonstrated: a broad field of competences, a strong commitment to customer service as well as the ability to apply pragmatic solutions for difficult problems. Their patient but persistent approach is a basis for a pleasant and fruitful relationship. I recommend Congenius as an all-round Quality and Regulatory contractor for the MedTech industry”
Director of Quality
“We managed to improve our Quality Management System with the support of Congenius. Specifically, we have been able to achieve substantial and sustainable progress in our processes and key quality indicators, especially as it relates to our CAPA & Post Market Surveillance areas. In addition to this, Congenius has been of key support in upskilling our employees and ensuring we are internally set up for success going forward. Since we first brought Congenius on board, we have made good strides, which has been noticed both internally and by our regulatory partners.”
Director of Quality
“Having worked with many consulting agencies in the past, the difference with Congenius is clearly in its people who work with passion and a commitment to excellence. I can say without a doubt that my interactions with Congenius personnel have been fantastic, both from a knowledge & skillset standpoint, as well as their integrity & character. It is a pleasure to work with them and we would not be where we are today without their support. I wholeheartedly recommend them to any organisation looking to take their Quality Management System to the next level.”
As a manufacturer of medical products, we depend on a competent partner in the demanding regulatory environment, who can support us promptly and creatively. In Mr. Dogwiler we have not only found the right sparring partner to support us in the creation of our quality management system and a consultant to assist with external audits, but have also learned to appreciate him more and more in the course of working together because of his personality, and his ability to approach things pragmatically. We are looking forward to our further cooperation and can highly recommend Congenius as a reliable partner.
News & Knowledge
MedTech news round up February
Our February MedTech news round up covers the EU Commission’s new information on the management of legacy devices and IVDs,…
MedTech news round up January
January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken…
5 learnings from FDA’s new Biocompatibility guidance
In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin. Our…
MedTech news round up December
This month`s MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on Electromagnetic…
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…
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