Clinical Evaluation Report

The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This half day course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.

About Clinical Evaluation Report

Goal:

To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.

Who benefits:

Clinical affairs, QA/RA specialists, risk managers, marketing.

Course Leader:

Anette Sjögren, PREVENTIA AB

Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.

Language:

Course material is in English.

Presentation in English or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

About Clinical Evaluation Report

Goal:

To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.

Who benefits:

Clinical affairs, QA/RA specialists, risk managers, marketing.

Course Leader:

Anette Sjögren, PREVENTIA AB

Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.

Language:

Course material is in English.

Presentation in English or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

Management Systems Training

 

Opplæringsmetodikk og fordeler

DNVs opplæring kombinerer revisorkompetanse, dataanalyse og LMS-tilgjengelighet (Learning Management System).

 

Helse

Enhver pasient skal få den beste behandlingen verden over

 

HMS og risiko

​Lær hvordan du kan identifisere og jobbe med risikoelementer i dine prosesser, oppgaver og aktiviteter gjennom et av våre kurs innen HMS og risikostyring.

 

Infomasjonssikkerhet og IT sikkerhet

Informasjon er en viktig ressurs for enhver bedrift, men den innebærer også spesielle forpliktelser

 

Kvalitetsledelse

​Kvalitet kan oppnås gjennom etablering av prosesser, måling og forbedring. DNV arrangerer en rekke kurs som dekker ulike områder av et styringssystem for kvalitet.

 

Medical devices training

Production of medical devices is a strictly regulated business. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance

 

Miljø og energi

Offentlig bekymring for miljø- og energispørsmål, strengere miljølovgivning og økt medieoppmerksomhet stiller større krav til bedrifter i dag

 

Risikohåndtering

Formålet med risikostyring er ikke å eliminere risiko, men å forstå den slik at du kan dra nytte av oppsiden og minimere nedsiden.

 

Samfunnsansvar

Samfunnet stiller høye krav til hvordan bedrifter arbeider med og rapporterer sitt samfunnsansvar. Våre kurs setter fokus på flere områder innenfor samfunnsansvar og er praktisk rettet for at du skal kunne jobbe effektivt for en trygg og bærekraftig fremtid.

 

Sjømat og mattrygghet

The food and beverage industry is moving to satisfy demands from international consumers and to open new market opportunities