Honkasalo Systems About usServicesContact Finnish

English


kj
Pic

OVER 20 YEARS OF PRODUCT LAUNCHES AND BUSINESS DEVELOPMENT SERVICES

Honkasalo Systems


Honkasalo Systems is a business development and auditing company. We help our clients to build and certify management systems conforming to the following standards:
  • ISO 9001: quality management system
  • ISO 13485: development of medical devices
  • ISO 14001: environmental management system
  • ISO 45001: occupational health and safety management system
  • ISO 27001: information security management system
Honkasalo Systems is committed to work together with our clients to find sustainable solutions that provide tangible results in a short time. Honkasalo Systems builds processes conforming to their requirements but keeps them lean and agile. This way we ensure bureaucracy does not kill innovation.

Honkasalo Systems assists clients to fulfill the regulatory requirements and to obtain required regulatory approvals, registrations and permits, for example:
  • EU General data protection regulation (GDPR)
  • EU Medical device regulation (MDR)
  • EU In-vitro diagnostic device regulation (IVDR)
  • EU Low-voltage directive (LVD)
  • EU Electromagnetic compatibility directive (EMC)
  • EU Restriction of hazardous substances in electrical devices directive (RoHS)
  • EU Chemical directive (REACH)
  • FDA quality system requirements (QSR)
  • etc.
Fulfilling the requirements listed above requires following harmonized standards. In addition to direct product requirements, harmonized standards also concern product safety, performance and stability evaluation, risk management and product realization process. Honkasalo Systems will assist the client to recognize the harmonized standards applicable to their products and operations.



-
**
Copyright  2018 Honkasalo Systems. All rights Reserved