Quality Management Systems

Certification

Audits and Inspections

Interim Management

Trainings

Quality Management Systems

Quality Management Systems are required in various regulatory systems. The aim is to establish procedures and controls to ensure that devices and pharmaceuticals meet their specifications. We can assist you in establishing a Quality Management System that meets your needs or in streamlining processes within your organization in order to increase efficiency for following standards and requirements:

  • Medical devices
    • EN ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
    • FDA Quality System Regulations 21 CFR Part 820
    • Canadian Medical Devices Conformity Assessment System (CMDCAS) Quality
    • Brazilian Good Manufacturing Practice (GMP) quality system requirements
    • Japanese Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents JP 169
  • Pharmaceuticals
    • Good Manufacturing Practice GMP
    • Good Clinical Practice GCP
    • Good Pharmacovigilance Practices GVP

Certification

Certification of Quality Management Systems by Notified Bodies play an important role. The certification is not only proof that the QM system established by the company conforms to the regulatory requirements, but also a crucial passport to enter the global market. We provide support to our customers in preparing for certification audits and selection of Notified Body.

Audits and Inspections

Audits and inspection help to ensure compliance with applicable quality system standards or quality systems regulation. We can either support your internal audit team or perform independent audits to assess your quality system

Our auditing / inspection services include:

  • Preparation and/or accompaniment of Notified Body Certification or Surveillance Audits
  • Preparation and/or accompaniment of FDA inspections using the Quality Systems inspection Technique QSIT
  • Audit of your contractor or supplier
  • Completion of gap analysis to determine compliance with FDA QSR, ISO 13485, Japan PAL, Brazilian GMP and/or Canadian CMDR

Interim Management

Healthcare is a dynamic industry and quality management is crucial to ensure continued success of a company. We assist our clients for a couple of months up to several years either as specialist or executive. Some typical examples for short-term resource needs are

  • Maternity/paternity leaves
  • Ongoing recruitment in growing teams
  • Internal re-organization
  • Temporary increase of workload

Trainings

We provide training to your organization

  • Quality system requirements in specific countries
  • Do’s and Don’ts during Audits and Inspections
  • Similarities and Differences between ISO 13485 and FDA QSR
  • Good Documentation Practice
  • Individual coaching