Regulatory consulting and market access strategy service for medical device manufacturers. Provides guidance on international compliance requirements, human factors integration, and product development pathways to facilitate market entry across multiple regions.
Manufactured by
Emergo by UL
Austin TX, United States
Emergo by UL offers a single-source solution for bringing medical devices to established and emerging markets. Choose from either SaaS or traditional consulting options to help manage your business. Your partner for medical device, in-vitro diagnostic regulatory affairs management Emergo was founded in 1997 with a mission to help medical device and IVD manufacturers manage regulatory affairs compliance and expand into new markets. We have grown into a global solutions provider specializing in end-to-end regulatory affairs/quality assurance life cycle management. Our unique services include local project managers and local sales teams partnering with global RA/QA experts for product lifecycle management. In 2017, UL Solutions acquired Emergo. UL Solutions depth and breadth of nonclinical testing expertise complements Emergo s global device registration, quality management, in-country representation, and related services. By joining the UL enterprise, Emergo can offer customers more comprehensive support for medical device registration, QMS compliance and now, nonclinical testing and certification to get products to market faster.
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Asia Actual · United States
Regulatory consulting and market access support for medical devices across Asia. Services include expedited registration, independent license holding, product importing, and commercial market entry assistance. Enables medical device manufacturers and distributors to navigate complex Asian regulatory pathways and accelerate product launches.
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Regulatory consulting service specializing in Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance. Provides strategic guidance and hands-on support for medical device market authorization and regulatory submissions across European markets.
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