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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

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Worldwide
Independent Regulatory Representation for Medical Device Companies
Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting.
multiple markets
Medical Device Design, Process and Software Validation Services
Regulatory agencies such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers.
multiple markets
ISO 14971 Risk Management Training for Medical Device Companies
The requirements contained in ISO 14971 provide medical device manufacturers and suppliers with a framework to manage the risks associated with medical devices.
multiple markets
Medical Device Gap, Internal, Pre-Certification and Supplier QMS Audits
Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with the appropriate regulations and standards.
multiple markets
Medical Device Internal Auditor Training for ISO 13485 & FDA QSR
For device manufacturers, compliance with ISO 13485, US FDA, European, Canadian, and Japanese regulations can be challenging and conducting proper internal audits is a big part of maintaining compliance.
multiple markets
On-Site ISO 13485:2016 Training
ANSWERED ON THIS PAGE: How do we involve our entire team in the ISO 13485:2016 implementation process? What do our employees need to know about ISO 13485:2016 to maintain compliance? Is there an efficient, cost-effective way to train our team on the QMS system?
multiple markets
ISO 14971 Risk Management Consulting for Medical Device Companies
ANSWERED ON THIS PAGE: What does ISO 14971 require? How do I implement ISO 14971? How do I apply the risk management system and concepts to my product?
multiple markets
Short Term or Part-Time Medical Device QA/RA Outsourcing
In today's fast changing and increasingly complex regulatory environment, many companies are choosing to outsource some medical device regulatory affairs and quality assurance tasks as a way to ensure quality system and regulatory compliance.
multiple markets
Medical Device Classification Consulting
The classification of your medical device determines the path you take through the registration process in nearly all countries.
multiple markets
ISO 13485 Consulting and Implementation for Medical Device Manufacturers
ANSWERED ON THIS PAGE: Why do we need ISO 13485 certification? How will ISO 13485 certification benefit our company? What is involved in the implementation process?
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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.