EC-certificate

EC-certificate

EC-certificate

Product catalog summary

Certificate Overview

This document is an EC Certificate for Production Quality Assurance System issued to Monark Exercise AB by RISE Research Institutes of Sweden AB. It certifies that Monark Exercise AB's quality system for the production, final inspection, and marketing of ergometer bikes and associated medical devices complies with the requirements of Annex V of Council Directive 93/42/EEC on Medical Devices, as amended by Council Directive 2007/47/EC.

Certificate Details

  • Certificate Number: 153601
  • Originally Issued: 2010-03-25
  • Decision Date: 2020-09-23
  • Expiry Date: 2024-05-26
  • Notified Body: 0402

Conditions for Validity

  • Surveillance audits must be performed with approved results.
  • Monark Exercise AB must notify RISE of any product modifications or significant changes in the quality system.
  • The certificate must not be used misleadingly in marketing activities.
  • RISE must be informed of any vigilance actions.

Basis for Certification

  • The quality system documentation was assessed by RISE according to LVFS 2003:11, Annex V.
  • Initial and follow-up audits were conducted at the company's premises in Vansbro.

Surveillance and Audits

RISE will conduct regular surveillance inspections and unannounced audits every three years to ensure compliance with the quality system requirements.

Product Register

The certificate covers various products, including Cardio Care 827 E, Ergomedic 828 E, Monark LC4, and Monark Medical Treadmill, among others. New products are highlighted in bold.

Certificate History

The certificate has undergone several revisions and extensions since its initial issuance in 2010, with updates to product lists and conditions.

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Catalog excerpts

EC-certificate-1

EC CERTIFICATE PRODUCTION QUALITY ASSURANCE SYSTEM CERTIFICATE Cert no. 153601 issued to Monark Exercise AB Kroons väg 1, 786 33 VANSBRO, SWEDEN We hereby certify that the Quality System of Monark Exercise AB for production, final inspection and marketing of ergometer bikes for active rehabilitation, training, fitness testing and work test, with associated patient connected equipment for measuring of heart rate medical devices in class IIa has been assessed with respect to the conformity assessment procedure according to Annex V of Council Directive 93/42/EEC on Medical Devices, as latest amended by Council Directive 2007/47/EC is implemented in Swedish Law by the national regulation LVFS 2003:11, and found to comply with the requirements This certificate applies to activities performed at Kroons väg 1, SE-786 33 VANSBRO, Sweden Originally issued Decision date Expiry date Issued by Notified body 0402 Signed by: Helén Dahl I am the author of this document 2020-09-23 13:32:38 +02:00 Helén Dahl RISE Research Institutes of Sweden AB | Certification Box 857, SE-501 15 Borås, Sweden +46 10-516 50 00 [email protected] | www.ri.se Accred. no 1002 Certification of Management Systems ISO/IEC 17021-1 Certificate 153601 | issue 11 | 2020-09-23 This certificate may not be reproduced other than in full, except with the prior written approval by RISE Certification.

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EC-certificate-2

EC CERTIFICATE Conditions Validity The certificate will remain valid until the expiry date, and allows the holder to use RISE notified body identification number 0402 in conjunction with the CE-mark, on products covered by this certificate, provided that the conditions stated below are fulfilled: - that surveillance audits are performed, with approved result; - that the company notifies RISE on all modifications on the products, and that the company does not apply the CE-mark to any new or modified products without confirmation from RISE; that the company notifies RISE on all significant changes...

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EC-certificate-3

Rl.SE Register of products covered by the certificate Note: New products in bold RISE Research Institutes of Sweden AB | Certification Sida 3(3) This certificate may not be reproduced other than in full, except with the prior written approval by RISE Certification.

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