ISO 13485 LI case studies

ISO 13485 LI · Put your knowledge to work in context.

The PECB Certified ISO 13485 Lead Implementer credential is aimed at professionals who establish, implement, manage and maintain a Medical Devices Quality Management System (MDQMS) based on ISO 13485. PECB lists managers and consultants involved in medical devices quality management, expert advisors, individuals responsible for maintaining MDQMS conformance, and MDQMS team members as the intended audience. The ISO 13485 LI case studies are 5 cases and about 5,338 words.

Scope statement, outsourcing and the own-brand pivot at a contract moulder

Meridian Ortho Components (MOC) injection-moulds and assembles single-use orthopaedic instrument trays for three customers who own the designs and hold the regulatory clearances. MOC's quality manager has drafted this scope statement: 'Manufacture and distribution of orthopaedic instrument trays.

965 words, about 5 min 2

Seven months to certificate: sequencing an MDQMS build at an 11-person IVD start-up

Nordlys Diagnostics has 11 employees and a point-of-care CRP assay for use in clinics. A European distributor has offered a supply contract conditional on an ISO 13485 certificate within seven months.

1,032 words, about 5 min 3

Resin substitution, cracked housings and a release decision on a running line

Cascade Medical Devices moulds and assembles the housing of the AeroMist home nebuliser, a Class IIa device, on a validated injection-moulding cell. In March the resin supplier substituted its polycarbonate/ABS blend with a 'technically equivalent' grade and notified Cascade six weeks later.

1,076 words, about 5 min 4

A CAPA system that closes everything and fixes nothing

Polaris Medical Systems has 240 employees and a mature ISO 13485 certificate. Its CAPA log shows 78 CAPAs opened in the last 12 months, 41 of them overdue beyond the 90-day target, and a mean time to closure of 128 days.

1,123 words, about 6 min 5

Four weeks to a certification audit: what to fix, what to disclose, what to postpone

Ardent Care Systems has its initial stage 2 ISO 13485 certification audit in four weeks at its main site. The certification body issued an audit plan: two auditors, 2.5 days, scope 'design, manufacture and distribution of infusion sets'.

1,142 words, about 6 min