Quality assurance during the product life cycle according to ISO 13485
PLG can support your company with:
- Definition and feasibility
- Design and development as well as verification and validation
- Design transfer and final validation
- Product launch and manufacturing
Services we offer your firm:
- Quality management system assessments and updates
- Document control implementation support
- Design control via strong management that supports the design history file and design master record
- Oversight of manufacturing and production processes
- Development of standard operating procedures (SOPs)
- Support of supplier quality and purchasing controls
- Postmarket surveillance implementation in the forms of plan, reporting, and updating
- Implementation of full set of validation templates for highly automated processes and computerized system validation
Quality compliance
PLG supports your firm with:
- Internal audit preparation in compliance with existing and incoming regulations: Medical Devices Directive (MDD) 93/42, Medical Devices Regulation (MDR) (EU) 2017/745, and FDA Quality System Regulation 21 CFR Part 820
- Good-manufacturing-practices alignment
- Quality management system (QMS) assessment according to current MDD, MDR, and Medical Devices Single Audit Program in the framework of ISO 13485
- Verification of QMS according to incoming MDR, supported by trained personnel using specific special tools and approaches, including ISO 17223
- Support to prepare external audits led by notified bodies or corporate
- Good document practices
- Complaints as well as corrective action and preventive action (CAPA), adverse events (AEs), and MDR processes and systems
Quality in production and product release
- Support in deploying quality control plan in production
- Support in confirming traceability in production and postproduction
- Support in establishing acceptance sampling plans
- Support in implementing statistical process control
- Device history record closure, including all documented evidence needed
- Support in lot release as required by good manufacturing practices