Consultant Services

Please find some of the areas where we can help! If you are specifically interesed in our services within the Medical Devices, please follow the link.

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

CE-mark

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