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medical device registration
Sterling medical Registration
Join our satisfied clients! If you ask them what made them choose us, you’re likely to get many different answers. There’s one thing they’ll all agree on though; we deliver outstanding results in record time.
Every medical manufacturing business needs someone to manage the quality system, internal audits, trainings, design & development, world wide products registration, safety & effectiveness. Whether you manufacturer or sell medical devices, STERLING MEDICAL REGISTRATION can help run your company's RA & QA tasks.
Sterling Medical Registration
We specializes in Regulatory & Quality consultation for medical devices companies. Our range of services offer complete solutions for Quality System Implementation, Design & Development Services, Medical Devices Registration all over the world. Our goal is to ensure that your company and your medical devices will meet the applicable regulation and specifications.
Sterling Medical Registration will assist you to achieve your market targets. With us you can do it right from the first time !
Our wide range of services offers: Medical Device Registration at the USA FDA - Premarket Notification 510K, Establishment Account, Listing, US Agent Services, Establishment of Quality Management System with accordance to QSR 21 CFR 810, ISO 13485:2016 Including MDSAP, Health Canada Medical Device Registration and other countries by customers' request.
EU Certification process with accordance to The European Union Medical Device Regulation of 2017 - MDR Regulation (EU) 2017/745 .
Implementation of International Standards ISO 11737, ISO 11137, ISO 14971, ISO 24971, ISO 11607, ISO 10993-1 and more.
Environment & Product Testing Evaluation, Coordination, Validation & Implementation such as Sterilization Validation, Dose Audit VDMAX, Clean Room Validation, Microbiological Testing, Sterility Test, Packaging Validation, Transportation Test and More.
Your Benefits of working with Sterling Medical Registration:
- Working with an experienced company.
- Enabling you entering the worldwide markets easily and efficiently.
- Ensuring that your quality system and medical devices will comply with the applicable regulations and specifications.
- Provide you with all required regulations before entering the target market.
- "One Stop Shop" Worldwide Medical Device Registration.
- Confidentiality of your Intellectual Property will be maintained.
- We will work with you and guide you through the entire project until your goals are achieved.
- We will provide you with fixed price to your defined requirements.