ISEMED and PROJECTCAD have just signed a partnership agreement for the design and development of the software that refers both to MDR and IVDR Regulations, whether "embedded" or "stand alone." The embedded software manages the operation of electromedical equipment, while the "stand-alone" ones are meant to run on IT platforms (Personal Computer, Server, Mobile App, etc.).
The purpose is to lead software projects, from design activities to optimizing the release of the required documentation to get the sales’ authorization in compliance with the current regulations.
Considering that the regulatory aspect can no longer be addressed as the final act of design, evaluating and managing activities from the earliest stages of a medical device or IVD design is necessary.
"I firmly believe that the partnership between ISEMED and PROJECTCAD can give rise to an innovative project with significant growth prospects, a new, more informed and structured approach to face and manage projects into a constantly evolving market" - says Fausto La Maida, CEO of PROJECTCAD.
"PROJECTCAD is part of the multidisciplinary partnership project that matches regulatory expertise to technical know-how in the software design and development field. We can thus offer the first service that integrates the project with all the technical required documentation to get the product CE marking" - says Guido Bonapace, founder and CEO of ISEMED.
PROJECTCAD was born and grew in the Automation, Pharma and Radiopharma Industries. Since 2010, the company has been alongside machine manufacturers by providing hardware, software and mechanical engineering solutions to give them concrete support to their development and affirmation in the market. Over the years, new professionals have joined the company, and new partnerships have been signed to provide a more complete and professional service. Today, ProjectCad can offer additional services such as project management, lean thinking, computer software validation, and prototyping.
Please find further information at: https://www.projectcad.eu/
ISEMED, founded in 2008, is based on high professional competencies in technical, quality and regulatory affairs developed in medical and industrial manufacturing companies and consultant for Notified Bodies. A continuous learning activity concerning Medical Devices, International Regulations and Technical Standards of its founder has been well recognized by Companies, Notified Bodies, International Education Societies and Bologna University.
Today, ISEMED is your best partner for developing a business plan on the international markets, considering all the mandatory steps in terms of time and cost-effectiveness.
Since July 2022, ISEMED is part of the Tentamus Group, a global network of specialized laboratories and service companies that works for quality and safety in the food, cosmetics, pharmaceutical and medical field. Please find further information at: https://www.isemed.eu
The purpose is to lead software projects, from design activities to optimizing the release of the required documentation to get the sales’ authorization in compliance with the current regulations.
Considering that the regulatory aspect can no longer be addressed as the final act of design, evaluating and managing activities from the earliest stages of a medical device or IVD design is necessary.
"I firmly believe that the partnership between ISEMED and PROJECTCAD can give rise to an innovative project with significant growth prospects, a new, more informed and structured approach to face and manage projects into a constantly evolving market" - says Fausto La Maida, CEO of PROJECTCAD.
"PROJECTCAD is part of the multidisciplinary partnership project that matches regulatory expertise to technical know-how in the software design and development field. We can thus offer the first service that integrates the project with all the technical required documentation to get the product CE marking" - says Guido Bonapace, founder and CEO of ISEMED.
PROJECTCAD was born and grew in the Automation, Pharma and Radiopharma Industries. Since 2010, the company has been alongside machine manufacturers by providing hardware, software and mechanical engineering solutions to give them concrete support to their development and affirmation in the market. Over the years, new professionals have joined the company, and new partnerships have been signed to provide a more complete and professional service. Today, ProjectCad can offer additional services such as project management, lean thinking, computer software validation, and prototyping.
Please find further information at: https://www.projectcad.eu/
ISEMED, founded in 2008, is based on high professional competencies in technical, quality and regulatory affairs developed in medical and industrial manufacturing companies and consultant for Notified Bodies. A continuous learning activity concerning Medical Devices, International Regulations and Technical Standards of its founder has been well recognized by Companies, Notified Bodies, International Education Societies and Bologna University.
Today, ISEMED is your best partner for developing a business plan on the international markets, considering all the mandatory steps in terms of time and cost-effectiveness.
Since July 2022, ISEMED is part of the Tentamus Group, a global network of specialized laboratories and service companies that works for quality and safety in the food, cosmetics, pharmaceutical and medical field. Please find further information at: https://www.isemed.eu
