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.
Our Operations Services
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.
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.
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 and Sterility 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.
– 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
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