As a result of increasing demands for high-value QA services, Medicologic has entered an agreement with Stig Larsson – renowned as a leading QA expert in the medical device industry.
The QA management field within medical device is changing rapidly these years and especially the upcoming CMDCAS / MDSAP requirements will impact many medical device and in-vitro diagnostics companies in the years to come.
Stig brings 30 years of experience within Quality management working both in the industry and as an external lead auditor. He has worked in numerous parts of the medical device industry as well as in other industries both in Europe and North America – and held key management positions responsible for projects, quality and logistics.
Medicologic clients are requesting consultants with good understanding of accredited certification and Notified Bodies, and with Stig’s experience from DS/DGM (Danish Standard association) and BVQI, this is expected to be a major asset for the future.
With the latest changes to the QA management set-up Medicologic now offers:
• Development and establishment of QMS according to ISO13485, CMDCAS, QSR 820
• GAP analysis – monitoring and adjustment of your quality management system
• Planning and execution of compliance audits according to ISO 13485, CMDCAS, QSR 820, MDD
• Support prior to, during and after market compliance audits (post inspections) by the competent authorities/Notified Body
• Risk Management according to ISO 14971 – Development of Risk Plan, Risk Analysis, Risk Management Report
• Labeling (Labels, IFU)
• FSCA, Customer Complaints
• Complaints Standard Updates
• Training ISO 13485 MDD / IVD
• Design Controls
Randi Hauerberg, partner at Medicologic highlights that by bringing Stig into the team:
“Medicologic now really has an edge in the medical device consulting market: Stig has extensive knowledge both as a lead assessor and in helping companies build, implement and maintain management systems. I believe we now have a combination of QA and RA skills that will help our clients succeed. Not many other consulting companies offer the same level of QA management understanding and this will soon prove crucial for many of our clients!”
Besides having a strong auditor and system knowledge, Stig is also an experienced teacher, coach and trainer and has numerous courses, internal audits and complaints handling sessions under his belt.
For more information:
Randi Hauerberg, Partner
Principal Advisor/Team Lead – Regulatory Affairs & Quality Management
Direct (+45) 22 47 01 55
Michael Funder, CEO
Direct (+45) 20 64 41 46