SEP. 18, 2020
➡️ Check out  reasons why your company should make sure to comply with Classification Rule 11 for Medical Device Software ☑️👌
Check out 3 reasons why your company should make sure to comply with Classification Rule 11 for Medical Device Software to avoid these risks
· 𝗠𝗮𝗿𝗸𝗲𝘁 𝘄𝗶𝘁𝗵𝗱𝗿𝗮𝘄𝗮𝗹
If you have an existing software that will be reclassified to class IIa or higher you risk to be forced to remove your product from the market if not compliant with the new MDR
· 𝗠𝗮𝗿𝗸𝗲𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝗹𝗼𝘀𝘀
Failing to develop and maintain software products compliant with the MDR will prevent you from gaining access to EU markets. Furthermore this could lead to consequences like costly product modifications or the delayed product launches
· 𝗔𝗱𝘃𝗲𝗿𝘀𝗲 𝗺𝗲𝗱𝗶𝗮
The media is growing increasingly diligent at holding companies accountable, especially in the areas of non-compliance and product safety. If your MDR regulated products are found to be non compliant with the quality management system or medical device approval process, adverse media reports could surface.
To help our customers to navigate through the new MDR we have developed an extensive MDR solutions portfolio including Training, Coaching & Mentoring packages as well as complimentary assessments
>>Click onto below button and find out how to get a complimentary assessment with our expert team to evaluate your current situation.