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

Outlook Microsoft Office 365 Google Tag Manager Mobile Friendly Nginx Bootstrap Framework Remote Circle

Keywords

medical equipment manufacturing in vitro diagnostics (ivd) regulatory documentation clean room validation mdr & ivdr compliance microbiological testing qms services risk assessment pharmaceuticals transportation validation regulatory compliance device design & development support device evaluation services regulatory intelligence other scientific and technical consulting services healthcare product registration regulatory affairs prrc - person responsible for regulatory compliance regulatory strategy medical device regulatory services brexit transition support global compliance services medical device software as a medical device (samd) services software as a medical device (samd) consultancy eu authorised representative (euar) mdsap audit services medical devices

Location

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

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