Medical Devices

Consultant services

We have extensive (more than 30 years) experience with international Regulatory Affairs and Quality Assurance. We will assist you with

• New product applications in USA (PMA, IDE, 510(k))
• CE-marking (EU)
• Development and implementation of Quality Systems (QSR - 21 CFR 820, ISO 13485)
• Risk Management and Risk Analysis of Medical Devices - ISO 14971
• Audit of systems, procedures and processes (21 CFR 820 QSR, ISO 13485, ISO 9001)
• Assessment of suppliers and contractors
• We manage, initiate, coordinate, organise the practical work in a clinical investigation. We report, monitor and audit the study

Training

We can assist you with internal training in order to develop the necessary competency for Regulatory and Quality Assurance in your organization

• Regulatory requirements for Medical Devices
• Medical Device Directive
• Quality Systems standards (ISO 13485, 21 CFR 820 QSR)
• Risk Management and Risk Analysis - ISO 14971
• Internal Audits

Read more about our in-house training

Pharmaceuticals

We have many years of international experience within the pharmecutical industry. We can support within many fields. As exemple:

• QAU, Quality Assurance Unit withing GLP
• QP, Quality Person, for pharmaceuticals
• Preparing quality systems according to the GLP, GCP or GMP requrements

We perform audits of companies (internal as well as external) towards GLP, GCP and GMP and support in evaluation of sub contractors. We run clinical studies from the application phase, through the study including monitoring and audits, and we run statistics and write the report.

Training

We perform internal training at your company. As example:

• Training in general regulatory requirements
• Training in GLP, GCP or GMP
• Internal audit training
• General statistics

Read more about our in-house training