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Good Choice is First Step of Success!

First Rule of Sigma Systems is Focus on Quality!

Our Collaboration on Projects Will Raise Your Business Above

the Expected!
Contact Us Our Team
Consulting
Medical Device Regulation in EU and US, ISO 9001, ISO 13485, ISO 14971, FDA QSR CFR 21 Part 820, CE marking, Technical File requirements, Preparing QMS Documentation, MDD 93/42/EEC, Quality Control and Improvement of Process, FMEA, Ishikawa, Pareto Analysis, 5 Why, PDCA, KaiZen, Auditing, Improvements
Quality Management System Development
ISO 9001, ISO 13485, ISO 14971, FDA QSR CFR 21 Part 820, MDD 93/42/EEC, IVDD 98/79/EC
Audit and Gap Analysis
According to ISO 9001, ISO 13485, ISO 14971, FDA QSR CFR 21 Part 820, MDD 93/42/EEC, IVDD 98/79/EC, Review of the TF for CE Mark - Auditing
Technical File and CE marking
CE marking - Technical File Requirements, Preparing TF for Medical Device, MDD 93/42/EEC, EN 62304 Medical Device Software Life Cycle Processes, EN 62366 Usability Engineering for Medical Devices, Project Documentations, Risk Analysis, IEC 60601-1 Medical El. Equipment:Gen. Requirements - Safety, IEC 60601-1-2 Electromagnetic Compatibility (EMC).
More than 10 Years of Experience
  • Development of QMS documentation according to ISO 13485, MDR – Regulation (EU) – 2017/745.
  • Regulatory support with QMS documentation according to MDSAP.
  • Regulatory support with Technical Documentation (Technical File) for Medical Device according to MDR – Regulation (EU) – 2017/745.
  • Development of QMS documentation according to FDA QSR 21 CRF Part 820.
  • Gap analysis according to ISO 13485, MDR – Regulation (EU) – 2017/745, FDA QSR 21 CRF Part 820.
  • Gap analysis of Technical Documentation according to MDR – Regulation (EU) – 2017/745.
  • Gap analysis related to Information Security according to ISO/IEC 27001.
  • Regulatory support with ISO 14971, IEC 62304, IEC 62366.
  • Regulatory support with Clinical Evaluation and MEDDEV 2.7.1, PMS, PMCF.
  • Support in Information Security according to ISO/IEC 27001.
  • Preparing QMS documentation according to ISO 9001.
  • Support in implementation processes according to ISO 13485 and MDR – Regulation (EU) – 2017/745.
  • Support in implementation processes according to ISO/IEC 27001, ISO 9001.
  • Support in certification process according to ISO 13485, ISO 9001 and ISO/IEC 27001.
  • Quality Management Systems and Regulatory Consulting for Medical and In-Vitro Diagnostic Device and CE marking.
  • Support in CE marking process according to EU regulations.
  • Preparing QMS documentation according to ISO 13485, IVDD/IVDR.
  • Preparing Technical File for In-Vitro Diagnostic Device.
  • Support in R&D Process and preparing project documentation for medical device according to standards and regulations,
  • Support in CE certification process for medical devices according to EU Regulations.
  • Preparation company for external audit according to ISO 13485, ISO 9001, ISO/IEC 27001 and MDSAP.
  • Education according to the requirements of ISO 13485 and ISO 9001.
  • Audit of TD for medical device (Class I, Class IIa, Class IIb).
  • Audit of MD-QMS according to ISO 13485 and FDA QSR CFR 21 Part 820.
  • Audit of MD-QMS according to MDSAP requirements.
  • Audit of process according to the requirements of ISO 13485, MDR – Regulation (EU) – 2017/745.
  • Trainings, Education and Workshops according to ISO 13485, MDR, ISO 14971, IEC 62366, IEC 62304, MDR – Regulation (EU) – 2017/745, PMS, ISO 15223-1.
  • Trainings, Education and Workshops according to ISO/IEC 27001.
  • Monitoring, Measurement, Process Analysis and Analysis of defects and failures in the production, (RCA) and (CAPA).
  • Support in preparation of RoHS Technical documentation - RoHS Technical Files according to 2011/65/EU.
  • Risk Analysis - Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) for MD.
  • Experience of lecturers (more of 1000 meetings and more of 1000 trainings, webinars, workshops).