Offers

The following are examples of prices and tools from CEPK - call us today or use the contact form on this page for further information:

Hourly rate for consultant services: 1000,- DKK (excl. VAT)

Clinical Evaluation Tool (1499,- DKK excl. VAT)

Create a well-structured clinical evaluation with this tool, which provides the basis for covering the requirements for clinical evaluation in Medical Device Directive (MDD). To ensure accurate and comprehensive compliance with the directive, MEDDEV guidelines from the European Commission have been used. In addition, the tool covers the requirements of the Medical Device Regulation (MDR), which enters into force 26 May 2021 – guidelines from the EU Medical Device Coordination Group (MDG) have been used to ensure compliance with the new regulation.
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.

Risk Management Tool (1499,- DKK excl. VAT)
Ensure patient safety with this Risk Management Tool, which enables you to evaluate risks for use of your product in compliance with Medical Device Directive (MDD). In addition, the tool covers the requirements of the Medical Device Regulation (MDR), which enters into force 26 May 2021. The international standard ISO 14971 is used in both cases to ensure compliance with the legislation.
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.

Quality Management System Tool CE & FDA (2999,- DKK excl. VAT)
Do you plan to market a product in both the EU and USA? Kill two birds with one stone using this Quality Management System Tool, which helps cover the quality system requirements for both CE certification and FDA clearance. The requirements for CE certification are covered for both the current regulatory legislation in EU, the Medical Device Directive (MDD), and the Medical Device Regulation (MDR), which enters into force 26 May 2021 – to ensure compliance for both MDD and MDR, the standard ISO 13485 has been used. The requirements for FDA clearance are covered through FDA’s Quality System Regulation (QSR), which is part of the regulatory legislation: Code of Federal Regulations (CSR).
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.

Quality Management System Tool CE (2499,- DKK excl. VAT)
This Quality Management System Tool provides the necessary bases for a quality system as part of your CE certification. The requirements for CE certification are covered for both the current regulatory legislation in EU, the Medical Device Directive (MDD), and the Medical Device Regulation (MDR), which enters into force 26 May 2021 – to ensure compliance for both MDD and MDR, the standard ISO 13485 has been used.
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.

Startup Tool MDD
Get started with CE certification of your product with this Startup Tool, which guides you through the preliminary stage of the CE certification process – the end result is based on your specific product, and will demonstrate the path forward for the full CE certification process. This Startup Tool is based on Medical Device Directive (MDD), which is applicable until 26 May 2021. To ensure accurate and comprehensive compliance with the regulatory legislation, MEDDEV guidelines from the European Commission have been used.
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.

Startup Tool MDR
This Startup Tool will guide you through the preliminary stage of the CE certification process. The result is based on your specific product, and will demonstrate the path forward for the full CE certification process. This Startup Tool is based on Medical Device Regulation (MDR), which enters into force 26 May 2021. To ensure accurate and comprehensive compliance with the regulatory legislation, guidelines from the EU Medical Device Coordination Group (MDCG) have been used.
Included in the price: 1 hour of video consultation with an RA/QA specialist from CEPK who will guide you through the templates.


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Free downloads:
QMS_excerpt_CEPK.pdf
Clinical_excerpt_CEPK.pdf
Risk_excerpt_CEPK.pdf
Startup_excerpt_CEPK.pdf