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Product and Services

December 21, 2012

Presafe´s extensive services range from design review of high risk medical devices to approval of class Is or Im medical devices according to the medical devices directive 93/42/EEC as amended, the in vitro diagnostic directive 98/79/EC , INMETRO, CAMDCAS, as well as certification of management systems according to ISO 13485 and ISO 9001:
  • 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.

Testing

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.

Certification

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.

Training

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!

Email: info@presafe.com
Presafe Norway tel: +47 67578800
DGM Denmark tel: +45 39454999
www.presafe.com

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