PECB ISO 13485 Foundation case studies
PECB ISO 13485 Foundation · Put your knowledge to work in context.
The PECB ISO 13485 Foundation credential is an entry-level certificate for people who need to understand the basic elements of implementing and managing a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. PECB describes the two-day training course as covering the different modules of an MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. The PECB ISO 13485 Foundation case studies are 5 cases and about 3,049 words.
1Sterile Drape Contract Manufacturer: Bioburden Excursion After an Unannounced EO Cycle Change
You are the quality manager at a 14-person contract manufacturer that has held ISO 13485 certification since 2019. The company makes sterile single-use surgical drapes for three legal manufacturers.
629 words, about 3 min2SaMD Startup: Design Controls, Agile Sprints and an Unqualified Cloud Supplier
You are advising a nine-person software-as-a-medical-device (SaMD) startup that expects an ISO 13485 certification audit in 10 weeks. Its product is a Class IIa ECG interpretation application; a 510(k) is pending.
626 words, about 3 min3IVD Reagent Manufacturer: Complaint Trend, Supplier Change and a Weak CAPA
You are the quality lead at an IVD reagent manufacturer with 120 employees and an ISO 13485 certificate covering design, production, and distribution. Over six months, seven complaints from one hospital network report elevated imprecision at low analyte levels.
601 words, about 3 min4Private-Label Dental Chair Distributor: Legal Manufacturer With a Narrow ISO 13485 Scope
You are the quality manager for a 25-person distributor that sells dental chair units under its own brand name. Design and production are performed by a contract manufacturer in another country.
610 words, about 3 min5ISO 9001 to ISO 13485 Transition: Process Audits, Risk and Shop-Floor Documents
You are a consultant helping a 60-person dental handpiece manufacturer transition from ISO 9001:2015 to ISO 13485:2016. The company has been ISO 9001 certified for 10 years.
583 words, about 3 min