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Quality Management – keeping quality simple and effective

A Quality Management System comprises business activities to ensure a determined level of quality.

Technolution is certified according to ISO 13485: 2016. Our certification and our experience enable us to work within your Quality Management System as well as the Technolution Management System.

Furthermore, Technolution supports the development of regulatory strategy and activities through partnerships.

Ole Jakobsen

Owner / Axlab

Development of medical devices is a long and complicated process that Technolution has carried out with great expertise.

Lars Hansen

General Manager / PowerSense

Technolution is a competent development partner who takes on the task and delivers results beyond our expectations regarding both quality and speed.

Technolution Management System (TMS)

The Technolution Management System is the foundation for a risk-based approach to development of medical devices that leads to high quality products which meets regulatory requirements and standards.

Technolution’s consultants are experienced in bridging regulatory requirements, value adding Quality Management and the creativity of the R&D departments at a sufficient level that satisfies all parties.

Technolution is certified according to ISO 13485:2016, including Risk Management and Usability Engineering activities. Our certification and our experience in working within our clients’ quality systems make the cooperation efficient.

Quality Management Systems (QMS)

Technolution uses business processes as the foundation for a risk-based approach to develop, implement and continuous improve Quality Management Systems.

ISO 13485:2016

Medical devices – Quality management in the development of medical devices

 

Technolution Management System is certified according to:

ISO 13485:2016
Medical Devices – Quality Management Systems Requirements for Regulatory Purposes

 

Technolution Management System is also in compliance with:

Medical Device Directive
Council Directive 93/42/EEC of 14 June 1993
In vitro diagnostic Medical Devices
Council Directive 98/79/EC of 27 October 1998
ISO 14971:2012
Medical Devices – Application of Risk Management to Medical Devices
 
ISO 14971:2007
Medical Devices – Application of Risk Management to Medical Devices
 
IEC 62366-1:2015
Medical Devices – Application of Usability Engineering to Medical Devices
 
FDA Guidance
Applying Human Factors and Usability Engineering to Medical Devices
 
ISO 15378:2012
Primary Packaging Materials for Medicinal Products
 
ISO 10993-1:2009
Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
 
21 CFR Part 820
Quality System Regulation

Let's have a look at your next quality management project. Reach out to

Marianne Lind ‧ Quality Manager

Give Marianne a call    or   Drop hER a line

 

Our Capabilities

QMS – Quality Management Systems

  • Integration of business and quality processes
  • Development and implementation of procedures and templates
  • Training
  • Internal audit
  • Supplier audit
  • Support to Notified Body audi

TMS – Technolution Management System

  • Support to medical device development
  • Support, review and approval of documentation to meet the regulatory requirements and standards
  • Support to regulatory strategies and activities

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