Case Study: Orthoplastics achieves US and European regulatory compliance with Ideagen Q‑Pulse

Orthoplastics meet their US and European regulatory requirements with help from Q-Pulse

Orthoplastics, a UK manufacturer and subcontractor of medical-grade UHMW‑PE for the orthopaedic implant market, faced intense US and EU regulatory scrutiny and frequent internal, supplier and third‑party audits. Certified to multiple standards (ISO 9001, 13485, 17025, 14001, OHSAS 18001) and subject to FDA and EU device rules, the company needed a user‑friendly, cost‑effective system to improve traceability and control of documents, audits and corrective/preventive actions (CA/PAs).

Ideagen implemented Q‑Pulse as a centralized compliance platform for electronic document control, auditing and CA/PA management, with interlinked modules and role‑based access. The system enabled attachment of supporting evidence, reduced document handling and processing time, improved visibility across QEMS, cut the risk of overlooked actions and accelerated CA/PA completion — allowing Orthoplastics to demonstrate regulatory and customer compliance on demand.

Orthoplastics

Chris Turner

Quality Manager