We provide consulting for Electrical Medical Device regulatory affairs to manufacturers to help them achieve compliance with global medical regulatory requirements.
Element’s engaged experts (scientists, engineers and regulatory advisors) consult with manufacturers on regulatory strategies for existing and new products, focusing on device commercialisation, management system implementation and the preparation of documentation. We also offer a comprehensive portfolio of training in key areas of regulatory affairs to help companies understand and develop their own regulatory strategy and develop products in the most cost-effective and flexible way.
Element’s technical experts understand the challenge of exporting medical products to the global market and assist manufacturers to achieve increased speed to market and successful product launches by providing the following services:
- Bespoke training
- Managed test programs
- Planning and support
- Documentation review and assessment
- Managing product and QMS approvals.
Our medical regulatory affairs experts help manufacturers of medical devices with product registrations, quality management systems and approvals and can help secure international and country-specific regulatory assurance and compliance for your products. We can help with global approvals for medical devices and assist you in getting your product to the global market by providing guidance on:
- CE Marking
- FDA QSR
- ISO 13485
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Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.
More from Element
Early Stage qualification
Our regulatory affairs team incorporates Engaged Experts that have clinical expertise and who have performed regulatory affairs roles in other organizations making them ideally suited to providing the guidance and advice needed to get your product through the regulatory requirements as quickly and efficiently as possible.
Element has a dedicated team providing ISO 17065 accredited Certification Services from our offices across the globe.
Element can serve as your single point of contact for all of your global product approvals.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing, environmental simulation to EMC and wireless device testing.