The eHealth environment is fast evolving and highly competitive. Committing to patient safety as the top priority, we ensure our eHealth team maintains an adaptable attitude and diverse skillset.
At Congenius, our eHealth consultants possess the multi-faceted knowledge, experience and skillsets needed to facilitate innovation, combining in-depth knowledge of regulations and software-development know-how with effective project management. We continuously develop our knowledge of the digital environment, keeping abreast of new regulations, new challenges, and new technology, to help you advance your projects effectively.
We can help to facilitate the successful creation of your Digital Systems, offering support in the development of SaMD Platforms for eHealth, mHealth and Digital Health. Find out more below.
Our eHealth Services
SaMD Requirements Management
Requirements management is the systematic approach to gathering, organising, documenting, and managing both the initial and the changing requirements of a system.
We can support you with collecting, organising, creating and maintaining documentation in ALM systems such as Polarion or Jama, and with conducting requirements reviews to help you with effective management of your SaMD requirements.
SaMD Risk Management & Cybersecurity ISO 14971, UL 2900
Performing product risk management is a central component of compliant product development.
We can support you with setting up your risk management process in accordance with ISO14971 & UL2900 (Cybersecurity) and other applicable standards, creating a product risk management file, or moderating the implementation of top-down & bottom-up risk analysis techniques relevant to SaMD. Our expertise in this area will help you stay in control of your potential product risks.
SaMD Lifecycle Management IEC 62304, IEC 82304
Any stand-alone software that is classified as a medical device must meet the requirements of ISO13485, IEC62304 & IEC82304.
These standards set out the minimum requirements for the most important SaMD lifecycle processes. Generally, a comprehensive QMS is utilised to ensure compliance with these standards. We can supply you with knowledgeable and experienced Regulatory Engineers to support the creation, updating and maintenance of your SaMD QMS and related technical documentation (DHF,DMR).
SaMD Usability Management IEC 62366
SaMD Usability engineering develops the requirements of user interfaces 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 hazardous situations due to poor usability and to define a process for ensuring good usability. Our Usability experts can help you install a UX/HFE development process that adheres to this and other relevant standards, supporting you by demonstrating the correct use and implementation of usability engineering for your SaMD.
SaMD Project Management
Should you require extra resource, we offer tailored project management services spanning the full scope of SaMD product development.
Our knowledgeable and experienced Project Managers offer a broad perspective, providing reliable assistance in the development of SaMD systems and products from idea inception, to successful development, to certification and market introduction, to life cycle management and to eventual product retirement.
SaMD Data Privacy & Security
GDPR & HIPAA influence SaMD developments and deployments by enhancing the privacy and security of medical records for the global community of users.
EU and FDA have recently issued further guidance which defines activities necessary at many of the key stages of the development process. We can help you navigate this rapidly evolving and complex topic to ensure the best outcomes for your users.
SaMD Process & Design Controls Definition
The rise of the Internet of Things, Wireless Connectivity, Cloud Computing, Artificial Intelligence and Machine Learning are just a few of the innovations that have prompted the need for a broader outlook for SaMD process definition and design controls.
Agile Processes and Continuous Integration are being increasingly utilised in the SaMD development process and platform strategies for efficient Mobile App, Web and Back-End Server systems software developments are rapidly evolving. Our consultants can help to guide you through these complex topics as you navigate the effective development of your device.
– 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.”
– 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.
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