Element is the ideal partner to help manufacturers of electrical medical devices obtain the safety testing and certification needed to deliver a regulated, safe and reliable medical device to the end user.
We provide medical device manufacturers with the ability to identify the appropriate safety testing standards and remove both cost and risk out of the product verification and validation process.
Element is UKAS accredited to BS EN ISO/IEC 17025:2005, compliant to the medical safety standard IEC 60601-1, which is recognised by public health authorities in most countries and is the harmonised standard for medical equipment under the Medical Device Directive 93/42/EEC. We are a National Certification Body (NCB), and a Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components.
We understand that the international standard for Application of Risk Management to Medical Devices is a mandatory requirement when demonstrating compliance to the 3rd Edition of EN/IEC 60601-1. Without this documentation, compliance to EN/IEC 60601-1 3rd Edition is not possible; we can assist you with this and provide support and guidance on ISO 14971 risk management including:
- Bespoke and one-to-one training
- Documentation and procedure review
- Production of essential documentation
- Mentoring and retainer contracts
Our safety experts understand the challenge of electrical safety testing of medical products for exporting to the global market and assist manufacturers in achieving increased speed to market, resulting in successful product launches.
To learn more about how our medical safety testing and consultancy services can add value to your design and testing, contact us with your specification and requirements.
Complimentary / Related Services:
For those that need guidance on the regulatory requirements for a particular product we can provide Early Stage Qualification (ESQ®) services to support them through the testing and approval of wireless products and components.
Our Certification team provides the Certification Services required for Market Access for North America, Japan and Korea as well as Notified Body Services for Europe.
Element's Global Approvals team provide services to help those looking to export their radio products into the Global Market place.
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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.
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