Peter J Andersson

Current

• Senior Consultant at Medos AB

Recommended

1 person has recommended Peter J

Connections

121 connections

Industry

Medical Devices

Peter J Andersson’s Summary

10+ years experience of regulatory affairs for medical devices. Business areas are Radiology IT (PACS, RIS, etc.) and Digital Mammography. Provided more than 20 successful 510(k)s for this area.

10+ years experience of methods and process improvement for software design.

10+ years experience of quality management systems (QMS) implementation and improvement, including internal QMS auditing according to ISO 9001:2000, ISO 13485:2003, and cGMP for medical devices QSR.

Peter J Andersson’s Specialties:

Regulatory Affairs, Quality Audits, Operational Excellence, Operational Development, Leading Change, Change Management, Quality, Quality Management, Process Metrics, Quality Metrics

Peter J Andersson’s Experience

• Senior Consultant

  Medos AB

  (Privately Held; 1-10 employees; Medical Devices industry)

  June 2008 — Present (1 year 6 months)

  Medical devices regualtory affairs advice, market clearance activities, operational development, change management, project management, software lifecycle consultancy, etc.