We offer strategic consulting services for the development and approval of medical devices, as well as first-class expertise in regulatory issues, quality management, user testing and pre-clinical work. 

As your sparring partner, we guide you safely through the jungle of regulatory principles, quality and risk management to ensure that your particular idea succeeds in the market. 

We are happy to follow you from start to finish, to ensure that you achieve your goals and that your product gets to market as quickly as possible. We help you structure processes, develop quality systems, write and quality assure documentation, and coordinate the project and the actors involved. 

Classification of the product according to relevant legislation is crucial for you and your product, as this defines the product and forms the basis for your product development plan to meet the necessary requirements and find its way to the market. Developing a medical device requires a quality system that complies with ISO 13485, and by following this system, you ensure that the entire process from design and development to testing, approval and production is carried out and documented in accordance with applicable regulations. 

Working on a regulatory plan also reveals which standards and requirements must be met for your specific product. Our experts structure further plans for your product, including documentation plan, test and validation plan, clinical evaluation, CE marking and market access, and coordinate outsourcing to third parties if necessary. 

Inventas helps you build, develop, strengthen and evaluate quality systems according to relevant statutory requirements and standards. We can also help your organization with inspection preparation before regulatory inspections, as well as support you with internal inspections or inspections of external suppliers to whom you outsource services. 

Our broad experience allows us to provide services and act as a quality assurance manager in your organization or project. 

Risk management is always an essential part of our methodology, and we also offer risk management services based on, for example, ISO 14971.

Our professionals have extensive experience in verifission and validation of mechanics, electronics and programvare. Inventas offers to define the strategy and support you throughout the entire lifecycle with requirements specification, risk management, procurement, development, testing and commissioning - to name a few examples. 

Usability engineering, also known as human factors engineering, is a methodological approach that focuses on how people actually use your product. The goal is to reduce the risk of user error and ensure that the product is both intuitive and safe.

IEC 62366 is an international standard, developed by the International Electrotechnical Commission (IEC), that sets guidelines for the quality of use of medical devices. The standard requires manufacturers to implement specific steps in the development process to ensure that the devices are safe and easy to use. In this way, manufacturers can document that their products meet regulatory requirements for both FDA approval in the United States and CE marking in the European Union.

In practice, this means that manufacturers must be able to demonstrate thorough testing and risk analyses that prove that the product can be used safely by healthcare professionals and patients.