Summary
- Profile Type
- Business Offer
- POD Reference
- BOIE20230209014
- Term of Validity
- 6 July 2023 - 5 July 2025
- Company's Country
- Ireland
- Type of partnership
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
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Their experts provide end-to-end support for Regulatory Affairs and have created several Quality Management systems for MedTech companies around the EU. They assist clients with representation services as a EUAR or PRRC. They specialise in USFDA and other global regulations too.
They can provide content for webinars and would welcome an opportunity to be a Regulatory Risk Partner - Full Description
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A regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies with a transition to a new medical device framework.
Services offered include
EU Authorised Representative
Regulatory Strategy for US, EU and the Rest of World
Assessments against new EU Medical Device / IVD regulations (2017) to assist with the transition to new requirements
Device classification & predicate device searches (US)
US FDA Regulatory Submissions
Clinical evaluations
Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
Technical file compilation
They have the resource, the scientific and technical know-how as well as the regulatory expertise to help fast-track your devices and IVDs to the healthcare services and the patients who are most in need. - Advantages and Innovations
- Have a strong track record with companies in regulation.
- Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- Secret know-how
Partner Sought
- Expected Role of a Partner
- A medical device production company that needs help with new regulations on the market
- Type and Size of Partner
- R&D Institution
- University
- SME 50 - 249
- SME 11-49
- Other
- Big company
- SME <=10
- Type of partnership
- Commercial agreement
Dissemination
- Technology keywords
- 09006001 - Quality Standards
- Market keywords
- 05007007 - Other medical/health related (not elsewhere classified)
- Targeted countries
- All countries