Below, please find more information on some of the areas that we can help you with!
We act as discussion partners and coaches for your 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.
We coordinate and manage projects for clinical investigations. We write the applications, protocol and other applicable documents. We monitor and audit the study.
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.