- Testing of medical electrical equipment according to the IEC 60601 series of standards
- Full quality assurance from design phase to finished product, integrated with ISO 9001 and ISO13485
- Assessment of environmental compliance
- Risk management
- Production surveillance through inspections or audits
Presafe can help with active and non-active medical devices, combination devices (devices including a medical substance), devices including human blood derivatives and in-vitro diagnostics devices.
Presafe operates through a broad network of testing laboratories and local facilities in all major markets around the world. Presafe is accredited according to EN 45011 (ISO/IEC Guide 65) and ISO/IEC 17025, and provides flexible and competitive solutions with quick turnaround times.
With over 50 part 2 (Particular) standards, Presafe is well equipped to ensure that products comply with international requirements.
Presafe tests medical devices according to the following standards:
- EN/IEC 60601-1 (General requirements for safety)
- EN/IEC 60601-1-xx (Collateral)
- EN/IEC 60601-2-xx (Particular) series of standards
Presafe can also test according to:
- Medical Devices Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
- EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (MDD Annex VII).
- EC Type Examination Certificate (MDD Annex III).
- Full Quality Assurance with reference to EN ISO 13485 (MDD Annex II).
- Production Quality Assurance with reference to EN ISO 13485 (MDD Annex V).
- Product Quality Assurance with reference to MDD Annex VI.
- EC Verification MDD Annex IV.
In the area of certification, Presafe provides:
- Technical documentation/file review or design dossier assessment.
- Production quality assurance equivalent to ISO 13485 (excluding design) according to Annex V.
- Full quality assurance equivalent to ISO 13485 according to Annex II.
- EC verification according to Annex IV.
- Guidance, interpretation and training related to the relevant directives for your products.
A world of knowledge can be brought to you through training programs at your premises or at Presafe´s offices in Norway and Denmark. Presafe´s training services can be delivered globally according to our customers´ cultural context.
Please visit our website or contact us today for more information!
Presafe Norway tel: +47 67578800
DGM Denmark tel: +45 39454999