Well designed is half done in product development and commercialization of health tech innovations. You can ensure the success of your product, save time and control total expenses when the product development is done according to the health tech requirements and in co-operation with users from the very beginning.
We can support your team in different phases of product development process.
We will walk all the way with you and make sure that your product can be CE-marked and certified.
From our offering you can find services related to development of medical software life cycle processes (IEC 62304), health tech innovation process, product development consultation, and technical realization.
Medical software life cycle processes IEC 62304
Software development according to the health tech field’s standard
IEC 62304 -standard extensively covers processes of medical software lifecycle: development, maintenance, risk and configuration management, and problem resolution.
Clinipower helps develop a life cycle model for your medical software according to IEC 62304, and apply the standard processes in practice within your organization. We make sure that the software development will be documented according to regulatory requirements.
Innovation process
A tailored process for health tech innovation journey to market
Health tech innovations result from co-operation of various actors and as an outcome of complex processes. The innovations are used in high-risk environments and placed on strictly regulated markets.
We at Clinipower have developed an innovation process that models the journey of a new health tech innovation MVP-version, from an idea to market. The process considers especially the beginning of the journey: recognizing opportunities and creating solutions. The process includes check lists for each phase for following progress.
You can contact us already when your product is on idea or concept level: we can map the potential journey to market with you.
Product development consultation
Utilize our extensive experience from the health tech field
Do you wonder what might be the best way to organize product development processes in the health tech field? We can offer your team coaching and consultation about organizing product development on practical level.
The consultation is carried out according to your needs and it can cover for example the following topics: defining product risk class as part of development, utilizing clinical and post-market data in product development project, and utilizing agile methods.
Technical realization
Evaluate feasibility and map out product realization methods
Medical devices are technological solutions which can be realized through various methods.
In terms of technical realization, we conduct technology mapping and can evaluate feasibility of a product concept from different perspectives. Our services also include technical architecture planning of products.
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How often should audits be conducted in a health technology company?
The frequency of audits in a health technology company is primarily determined by the requirements of the ISO 13485 standard and the MDR/IVDR regulations. Internal audits must be conducted in accordance with the audit plan defined in the quality management system. External audits performed by a notified body are carried out annually. The regularity of audits ensures the functionality and compliance of the quality management system.
EU4MEDTECH – Transforming Medical Technology Evaluation
European health technology development is undergoing a transition, and new regulatory requirements are challenging companies to find effective solutions. Clinipower…
CE marking for medical device
CE marking is a critical prerequisite for the successful marketing of medical devices in Europe. This mandatory marking indicates that the product meets all applicable EU regulations and is safe for its intended use. Health technology product development nowadays requires a deep understanding of the CE marking process from the early stages of development work, as considering regulatory requirements later can cause significant delays and costs. The new Medical Device Regulation (MDR) has significantly tightened requirements, and companies need even deeper expertise to navigate successfully in the complex regulatory environment. CE marking (Conformité Européenne) is a statutory compliance marking that indicates a medical device meets all applicable EU directives and regulations. Without CE marking, a medical device may not be placed on the market in the European Economic Area. The marking is the manufacturer’s declaration that the product has been designed and manufactured in accordance with applicable […]
Our experts
Pekka Kola
Senior Advisor, Technology and Architecture
Kimmo Vauhkonen
Senior Advisor, Quality and Regulatory
Juha Kaasinen
Senior Advisor, Usability and User Experience
