Sushvin Consultancy Services

medical devices

About

Sushvin Consultancy Services is a recognized expert firm in quality assurance and regulatory compliance for the medical device and pharmaceutical industries. Founded in 2011 by Aditya Kulkarni, the company provides tailored solutions to help manufacturers navigate complex international regulations, ensuring compliance across various regions, including the UK, EU, US, Middle East, and South Asia. The company offers a range of core services, including regulatory consulting, compliance strategy, validation, certification, and market access support for medical devices and in vitro diagnostics. Their expertise spans sectors such as Advanced Wound Care, Software as a Medical Device, Dental Implants, Orthopedics, and Drug-Device Combination Products. Sushvin’s approach focuses on building strong client relationships to deliver customized solutions, empowering clients to maintain compliance efficiently while prioritizing patient safety and facilitating global market entry.

Technologies

OutlookMicrosoft Office 365Google Tag ManagerMobile FriendlyNginxBootstrap FrameworkRemoteCircle

Keywords

medical equipment manufacturingin vitro diagnostics (ivd)regulatory documentationclean room validationmdr & ivdr compliancemicrobiological testingqms servicesrisk assessmentpharmaceuticalstransportation validationregulatory compliancedevice design & development supportdevice evaluation servicesregulatory intelligenceother scientific and technical consulting serviceshealthcareproduct registrationregulatory affairsprrc - person responsible for regulatory complianceregulatory strategymedical device regulatory servicesbrexit transition supportglobal compliance servicesmedical devicesoftware as a medical device (samd)servicessoftware as a medical device (samd) consultancyeu authorised representative (euar)mdsap audit servicesmedical devices

Location

210d Sundon Park Road, Luton, England, United Kingdom, LU3 3

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