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QMS Establishment: defining the scope of the quality system, developing efficient, user-friendly policies & Standard Operating Procedures (SOPs), selecting and customizing QMS software.
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QMS Implementation:
- Design & Development Control: design and V&V planning, preparation / review of testing protocols and reports, locating laboratories for product testing, transfer to production and process validation.
- Risk Management: risk management planning and risk analysis, according to ISO 14971 (2019).
- Production Control: purchasing control, production work instructions review, management of non-conformities.
- Supplier Control: supplier qualification, supplier evaluation plan, supplier / subcontractor / distributor audits / quality agreements.
- Quality Planning & Compliance: defining quality objectives and KPIs, internal audits, CAPA planning and execution, management and employee training, data analysis and management review.
- Post Market Surveillance (PMS): PMS planning, preparing / reviewing PMS reports, management of warning letters.
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Preparation for QMS Certification gap analysis, mock inspections, audit behavior employee training, audit operation management:
- ISO 13485 audits
- Medical Device Single Audit Program (MDSAP) audits
- FDA inspections
- MFDS (S. Korea) inspections
- INMETRO (Brazil) audits
- And more
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QMS Maintenance on-demand hands on service:
- Evaluation of Corrective Action Effectiveness
- Review of data integrity
- Specific, on-demand trainings
- Complaints management
- Control of measuring equipment
- Internal audits
- Facility environmental control
- Preparation for surveillance audits
- Maintenance of product files
- Mentoring of QC and QA staff
- Preparing / reviewing periodic reports
- And more
