Consultant Services

Below, please find more information on some of the areas that we can help you with!

Management advisors

We act as discussion partners and coaches for your quality improvement.

Quality Improvement

Result oriented projects with the target to decrease cost of poor quality and improve competitive strength

Quality Management Systems – development and implementation

Projects for ISO 13485 and 21 CFR 820 Quality System Regulations (QSR) and CGMP (Current Good Manufacturing Practice, USA)

Auditing Quality Systems

Planning, conduct and reporting Quality Systems Audit based on ISO 9001, ISO 13485 and 21 CFR 820 for improving your own or your suppliers Quality Management System

Risk Management and Risk Analysis

Planning, conduct and reporting of Risk Management activities including Risk Analysis of products and processes. We will use methodology according to your specifications (typically FMEA/FMECA) and we will use ISO 14971 as a guide line


We will assist you in CE-marking your Medical Device, Machine or Electric Products.

Biocompatibility and toxicology

We ccordinate activities according to the qualification requirements of the ISO 10993. We write reports and give advise.

Clinical Investigations

We coordinate and manage projects for clinical investigations. We write the applications, protocol and other applicable documents. We monitor and audit the study.

International projects

We work in Sweden, Germany, UK, Ireland, and USA with Medical Devices

Consultant Services

PREVENTIA has acted as independent consultants in Quality- Environmental- and Risk Management since 1989.

From 2005 we will focus on the Medical Device Industry in order to be able to provide still better service to our customers. We have been involved in projects in Sweden, UK, Germany, Ireland, USA and Holland in the medical device- general manufacturing- process- food- and service industry sectors.

Please contact us for a free discussion concerning our services and what we can do to help your organisation. We will do our outmost to exceed your expectations!