Regulatory Affairs & Market Access Services

Operating in Shannon, Ireland, our team of expert regulatory specialists and product safety engineers can assist you with guidance towards compliance and certification services for market access to a wide range of international markets.

At Cranage Veritas we put you at the heart of our business. We pride ourselves on our high quality service, and the importance of developing safe medical and electrical devices.

If you are not sure of the services you require, or do not see them below, please feel free to get in touch with us to discuss your project's requirements.

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Our experienced product safety and regulatory specialists are able to offer their valuable knowledge and expertise to assist you towards achieving compliance for your electrical or medical devices.

We can assist throughout your product's development stages and the entire product life cycle including post market surveillance factory visits.

Our regulatory guidance and advice services enable you to progress your project in line with national or international directives and regulations, reducing unnecessary and avoidable issues with your product approval process

View our regulatory guidance

Product certification schemes and conformity marks are used worldwide and are often required to gain market access.

Certification schemes can reduce the processes required to enter markets in different countries. We can assist you in attaining international product certification, and help you through your conformity declaration process, facilitating worldwide market access for your medical and electrical products. We can assist with:

On-site testing for machinery
CE, UKCA, UKNI Conformity Marks
Technical File Preparation
Authorised Representative

Go to market access

Our Authorised Representative services are essential for non-EU / UK companies seeking to market their products in Europe or the United Kingdom while ensuring compliance with the relevant regulations.

As we are based within the European Union we can act on behalf of a non-European company in fulfilling regulatory obligations.

Our role as the European Authorised Representative is to serve as the liaison between the manufacturer / importer and the regulatory authorities in the European Union. We ensure that all required technical documentation for the product is complete and accessible for regulatory authorities and in the majority of cases, prepare the necessary information or documentation including the Declaration of Conformity.

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Authorised Representative Services

Working closely with European medical device designers and manufacturers, our regulatory affairs experts offer multiple solutions for market access and product certification.

From initial guidance at the design concept, in line with IEC 60601-1 series, through to achieving full regulatory compliance against the MDR, we help you navigate the process of bringing a medical device to market with confidence.

We can also provide assistance for MDR Article 15 - Person Responsible for Regulatory Compliance (for EU Market Access), and FDA 510(k) Premarket Notifications (for medical devices intended on sale in the US).

View our medical device services

View Our Additional Services

Call us today: +44 7484 225788

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Regulatory Affairs and Market Access Services

Product Safety, Inspection, Certification and Regulatory Affairs
For International Market Access

Market Access and Certification Assistance for Electronic Device Manufacturers

Regulatory affairs guidance and advice

Market access services for Product Marking and Certification

European Authorised Representative

Medical Device Guidance and Certification

Additional Services

View Our Useful Information and Frequently Asked Questions

Helping You Navigate Global Market Access Requirements and Regulatory Affairs.

Cranage Veritas

Info@cranage.ie

Cranage Veritas Limited
Suite 232 Airport House
Shannon Free Zone
Shannon
County Clare
Ireland
V14N578