Regulatory Affairs and Market Access 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).

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

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.

Cranage Veritas 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