ISO 13485/GMP/GLP/GTP Quality System Consulting Service

ISO 13485/GMP/GLP/GTP Quality System Consulting Service

Service Scope

  1. USFDA Quality System Regulation/ ISO 13485 Quality System consulting
  2. EU-MDD/MDR system consulting
  3. Taiwan FDA Medical device GMP system(Good Manufacture Practice) consulting
  4. Labratory ISO 17025 system consulting
  5. OECD- Good Laboratory Practice, OECD- GLP system conuslting
  6. Human Tissue Bank and GTP (Good Tissue Practice) consulting

Since ISO 13485:2016 announcment, medical device industry have to upgrade original quality system to compliance with 2016 version before 2019/2, Voler Biotech Consulting proivde fully training and consulting service to medical deivce industry and assisted our client got certification after certified body audited.

Our Consulting Service flowchart
1.Quality system planning stage- current situation analysis, target determination, international regulations compliance , medical industry specific standards, verification scope, establishment of enterprise organization specifications and authority structure.
2. System development stage-regulation training at all levels, related standard management and technical standards are implemented and records are established and pushed forward.
3.System builting stage-standard procedure builting , operation process and risk assessment management system planning and construction.
4.System implementation stage-internal audit and correction, management review and system operation, correction and integration.
5.System certification stage-external audit certification services and missing counseling; including formal certification login and continuous maintenance of the system.