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!
Below, please find more information on some of the areas that we can help you with!
Management advisorsWe act as discussion partners and coaches for your quality improvement.
Quality ImprovementResult oriented projects with the target to decrease cost of poor quality and improve competitive strength
Quality Management Systems development and implementationProjects for ISO 13485 and 21 CFR 820 Quality System Regulations (QSR) and CGMP (Current Good Manufacturing Practice, USA)
Auditing Quality SystemsPlanning, 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 AnalysisPlanning, 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
CE-markWe will assist you in CE-marking your Medical Device, Machine or Electric Products.
Biocompatibility and toxicologyWe ccordinate activities according to the qualification requirements of the ISO 10993. We write reports and give advise.
Clinical InvestigationsWe coordinate and manage projects for clinical investigations. We write the applications, protocol and other applicable documents. We monitor and audit the study.
International projectsWe work in Sweden, Germany, UK, Ireland, and USA with Medical Devices