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