Honkasalo Systems About usServicesContact Finnish

English


kj
Pic

Timppa Honkasalo, M.Sc.

Director of Honkasalo Systems


Company History

Honkasalo Systems was founded 1995 to develop and maintain software in safety-critical industries such as health care. When EU directives regulating medical and diagnostic devices were changed to include also medical software, other software companies started to ask our help in obtaining CE mark for their products. During the years in health care product development we gained expertise about global marketing, risk analysis, process development and quality management systems and we changed our main emphasis from product development to consulting.

Today Honkasalo Systems advices companies in regulatory approvals, quality management systems and global commercialization. Our wide partner network enables us to offer ISO certifications, product development and hosting services.

Timppa Honkasalo

I am a business developer, subject matter expert and certified lead auditor with over 20 years of hands on experience in the global healthcare and medical and diagnostic device industry. I have worked in cross-functional positions including product realization to marketing and after-sales. My background is in software but I have also worked a long time with device assembly and chemistry production.

I am a certified lead auditor (CQI-IRCA delegate 62910) for:
  • ISO 9001 (quality management systems)
  • ISO 13485 (development of medical devices)
  • ISO 14001 (environmental management systems)
  • ISO 45001 (occupational health and safety management systems)
I have a deep knowledge in regulatory affairs related to medical devices and product safety, for example electrical and chemical safety. I am certified to perform gap analysis for EU medical and diagnostic device regulations (MDR and IVDR) as well as data protection regulation (GDPR).

I also provide training and development services for ISO 27001 compliant information security management systems and ISO 30001 and ISO 14971 compliant risk management systems.

The Way We Work

We operate in close co-operation with our clients and familiarize with the client's products, work habits and company culture. We believe that the processes work the best way when tailored to the client's needs. May clients have outsourced their quality management function to Honkasalo Systems and therefore we usually work in the client's facility.

Go back



-
**
Copyright  2016 Honkasalo Systems. All rights Reserved