The consequences of classification, launch markets, quantities, product road map, competition, COGS, etc are siginificant.
We help you with this first phase of a medical device development project.
SaMD / AI
Software as a Medical Device is regulated and requires the same level of documentation and validation as physical medical devices.
Artificial Intelligence (AI) offers enormous possibilities, but also headache in interpreting how to proceed.
We assist companies to choose and implement electronic Quality management Systems.
As a neutral provider, we let you decide, but offer discounts for a verity of systems, i.e. Qualio, and SciLife.
MDR 2017/745 requires more stringent more stringent PMS than under MDD - and ISO 20416 is both time consuming and difficult to comply to.
We help you from A to Z - from planning, to defining sources and data collection methods, to collection of data and creation of reports.
MDR 2017/745 is now law of the land in EU. Usability Engineering is mandatory and follows ISO 62366.
We help you to plan, set up formative and summative studies, and write the report.
Instructions for Use (IFU)
Instructions for Use are mandatory for most devices and require know how of regulatory aspects, UDI, country specific requirements, etc.
We have experienced consultants to help you with creation of labels, UDIs, manuals.
We help setup efficient manufacturing lines that comply to medical device regulatory requirements - GMP, Cleanrooms, simulation, 3D drawings, equipment procurement.
MDR 2017/745 has 22 rules in Annex VIII - new now is rule 14 that applies specifically to SW.
Classification is dependant upon the intended purpose - and often it is a strategic decision of the medical device developer - invasive, active, etc.