Traceability as key for marketability

The creation and marketing of medical devices is subject to increasingly complex regulations. On March 12th 2018, manufacturers and sales agents were invited to "Make Medical Device Creation Easier". The symposium by PLM specialist TechniaTranscat gave best practice examples and showcased how these regulations can actually be turned into great assets and improve product value.

By understanding the legal requirements as an opportunity to improve and standardize their own processes, manufacturers can integrate UDI, MDR, and IVDR to make their business fit for the future. The information required for registration and approval of a product is automatically collected in the PLM software. There, data is traceable, compliant and internationally standardized, and ready for retrieval.

“Manufacturers can improve the quality of their data right from the start, making it easier and faster to complete all stages. The software provides them with guidance to meet regulatory requirements throughout the approval and registration process," explained Smita Bhattacharjee, Product Manager at TechniaTranscat. "By leveraging PLM, organizations can improve quality control and eliminate potential lifecycle vulnerabilities, as well as simplifying recalls and warranties."

All the speaker presentations can now be downloaded here:

Introduction - Annelie Uvhagen, TechniaTranscat

Turning regulatory complexity into a competitive advantage with PLM - Smita-Bhattacharjee, TechniaTranscat

The new MDR and IVDR - these are the major changes:
General Overview of the Medical Device Regulation - Julia Müller, TÜV Süd

Using PLM to accelerate the delivery of innovative, safe and fully compliant medical devices - Thierry Dufresne, Dassault Systèmes

Examples of compliant operational solutions to create competitive long-lasting company advantages - Tommy Røsholt, William Demant Holding

End-to-end traceability in PLM from Complaints to CAPA to effective Change - Smita-Bhattacharjee, TechniaTranscat

For questions regarding the event or the presented issues please contact us:

Phone: +49 721 97043 - 16
info-center@techniatranscat.com