VIII. The large package “ready for the initial assessment”

27.900,00 

Description

Do you want to bring products requiring approval onto the market promptly and want to concentrate on product development? Then we will take care of everything you need to do to successfully master the initial assessment, including the initial assessment by an official representative!

Offer content:

Large package “Initial assessment guaranteed” (here approx. 3,000.- price advantage for an auditor from TÜV Süd)

Creating/revising the process descriptions for the initial assessment – depending on the status

  • Process for type approval
  • Process for change management (technical and formal changes)
  • Process for CoP-P incl. development of CoP control plan
  • Process for market surveillance
  • Process for recall management
  • Optimization of the organizational chart (ensuring “A-K-V”)
  • Procedural instructions for the test characteristics to be fulfilled

Training flat rate for “KBA appointees”

Participation in all relevant open training courses according to the event calendar for up to 3 participants:

  • Basic training in approval procedures
  • Basic training CoP
  • Basic training in market surveillance, RAPEX and recalls
  • Training videos for streaming incl.
  • Repeat option included (multiple participation in the same training content)

incl. Learning success control and certificates

Preparation of initial assessment

  • Identification Auditor Technical Service / Authority
  • Coordination with auditor in preparation for the audit
  • Clarification of open questions

Accompaniment of the initial assessment (at your premises)

  • Accompanying the audit as an “internal co-auditor”
  • Evaluation of the audit and possible deviations
  • Elaboration of lessons learned

Follow-up audit

In the event of major deviations from the processes developed by us, reworking is included.

And at a fixed price!

Your advantage

  • Fixed price without risk
  • Rapid, structured preparation for the initial assessment and development of all process descriptions for passing the initial assessment
  • Processing of all relevant documents from the authorities
  • Search for a suitable auditor from the authority or recognized by the respective authority and coordination of the audit date.
  • Complete communication with the authorities
  • Accompanying the audit
  • Follow-up of the audit by the authority
  • Short processing time, guaranteed success

Price

27,900 (for companies with up to 500 employees)

* travel expenses are not included

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