english
deutsch
we managed numerous international projects for different applications from the idea inception through registration and commercialization. take advantage of confinis’ network of leading companies in the pharmaceutical, biotech and medical device industries, authorities, laboratories, consultancies, independent professionals and suppliers.
your company needs a resource to take over a project on short term? our diversified
knowledge and skill set enable us to initiate projects and kick them off with
the appropriate principles and drive or to work into ongoing projects and
lead them towards a successful product launch.
establishing product development and manufacturing processes are services that face an increased demand from suppliers of the medical devices, pharmaceutical and biotechnology industries.
the definition of a suitable and structured process that fulfills all regulatory requirements (e.g. GMP – good manufacturing practices, QSR – quality systems regulations) and covers the entire product development as well as product manufacturing process, from the development of user requirements up to a verified, validated, registered and launched product, is one of confinis’ core competences.
with effective and efficient processes as well as an implemented corresponding
document system, quantum leaps can be achieved regarding quality and quantity
of the results. furthermore it reduces costs and facilitates on providing
positive results on internal or authority audits.
since january 1996 medical device companies are required to establish and maintain product risk analyses. the previously valid standard EN 1441 was replaced as of march 2001 by ISO 14971 which forces increased requirements regarding the management of risks.
confinis assists you in establishing the corresponding structures, processes,
document templates and documentation to fulfill these new requirements. confinis
performs internal trainings or provides moderation of the risk analysis process
together with your team. take advantage of our experience from dozens of completed
risk management files for development projects and marketed products - you
will not regret it!
unfortunately, many promising ideas fail to reach the market. the problem is rarely found in the idea itself or the founder’s commitment. Typically ideas failed due to the lack of attention to small but important details. confinis will assist your company to focus on doing the right things first (effectiveness) and then to do these things right (efficiency). in addition we can connect you with possible customers, authorities, consultants and suppliers from our diversified network. call us to discuss your needs, without obligations!
the stringent requirements regarding quality of programmable electrical medical devices set forth by the european and american authorities (FDA) call for detailed, well planned and structured processes as well as detailed documentation (traceability). we have extensive expertise and experience in the overall development process meeting both the european and american regulations and requirements. we can assist you in implementing it in your company.