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Predisys is a leading provider of quality control, quality management and collaborative manufacturing analytical solutions for medical device manufacturers.

The company’s flagship software product, Predisys Medical Device Suite, is an innovative Microsoft SharePoint based software solution that enables manufacturers to better support compliance, optimize processes, reduce documentation errors, increase efficiency and improve product quality.

With fully FDA CFR 21 Part 11 compliant electronic records management, medical device manufacturers can safely implement paperless systems to facilitate compliance, traceability and continual improvement while reducing documentation errors, eliminating missing or lost records, and increasing  overall production efficiency.

The web-centric and cost-effective Medical Device Suite is modular comes with integrated support for e.g.:  Device History Records (DHR),  Device Master Records  (DMR),  Corrective and Preventive Action (CAPA),  Nonconformance management (NCR),  Supplier Corrective Action Requests,  Quality Audits  as well as Management, Collaborative Online Statistical Process Control (SPC) and Advanced Engineering Analysis.

Keywords: quality control, quality management, SPC, statistical process control, business intelligence, FDA registration, ICT, MES, CAPA

Contact Information

Predisys Inc
Tietäjäntie 4
FI-02130 Espoo
Tel: +358 (0) 9 493 3420
Fax: +358 (0) 9 493 34299