• Quality Management System (QMS): Implementation, development, and maintenance in accordance with
• ISO 13485, MDSAP, EU GMP Annex 1
• Procedures: Implementation, development, and maintenance
• Management Reviews
• Supplier Management: Preparation and approval of quality agreements and supplier audits
• QA production support – CAPAs, NCRs, and Change Requests
• Equipment qualification
• Process and test method validation
• Batch review and release
• Employee training in procedures

• Regulatory strategy
• MDD to MDR
• IVD to IVDR
• MDR/IVDR Gap Analyses
• Product classification
• Technical file preparation for product registration
• Communication with global authorities and Notified Body
• CE marking
• Labeling

· Overall project management: from idea to product
· Risk management, ISO 14971
· User and design requirement specifications
· Design inputs/outputs
· Design verification and validation
· Design reviews
· Software development and validation, EN 62304
· Technical file

· FDA 21 CFR part 820
· MDR - Regulation EU 2017/745
· IVDR - Regulation EU 2017/746
· EU GMP, Annex 1

· Internal audit
· External audit
· Auditing and back-office suppor
· Inspection from authorities or Notified Body

• PMS plans
• PMS reports and PSURs
• FSCAs and recalls
• Incident and adverse event reporting
• Trend reporting