LinkedIn

Our Policy

Sterling Medical Registration can help you make sure you're getting professional Regulatory & Quality services to match your business requirements and objectives.
Our goal is to fully understand your needs, budget, timelines and expectations. Knowing what you currently have and where you would like to go is the first priority in any phase of the project. Gap analysis will be conducted in order to estimate and evaluate your organization structure, products and work to be done.
As with any business, planning is the key to success and with Sterling Medical Registration you can make it happen !

Our Expertise

Regulatory & Legal Activities

  • Medical Device Registration, Worldwide Experience: Argentina, Bulgaria, Brazil, Canada, China, Columbia, Europe, India, Israel, Korea, Mexico, Philippines, Russia, Taiwan, USA and more.
  • Govermental Licensing.
  • Distributors:  Search and Contract Handling.
  • European Representative Services.
  • Import & Export Regulations.
  • Trade Mark & Patent.

Quality activities

  • Quality System Implementation, Worldwide Experience:

            Israel, Canada, Europe, USA etc.

  • ISO Implementation: ISO 13485, ISO 9001, ISO 22716.
  • Technical File, CE: Establishment & Maintenance. 
  • Risk Management: ISO 14971, Establishment & Maintenance.
  • Design & Development.
  • Design Contol File, DHF, DHR, Establishment.
  • Product Testing.
  • Validation Programs.
  • Clinical Evaluations.
  • Clean Room.
  • QC Inspections.
  • Labeling .
  • Audits.
  • Trainings.
Quality Assurance Management

Establishment & Maintenance of a Quality Assurance System is an essential key to all medical device companies. With us you can ensure compliance with the applicable requirements.

Business Solutions

Our specialization is to bring your product from idea to realization and to enlarge your market strategy. With Sterling Medical Registration, you will be steps ahead !

Medical Device Registration

Entering a market is not a simple thing! Before start selling you must register your products and to comply with the local regulatory requierments, we can help!

Our Management

Sterling Medical Registration is headed by Daniela Levy, Advocate.

Regulatory & Quality Consultant who has 18 years of experience in the Medical Device industry.

Her competence in Regulatory &  Quality activities led to successful worldwide registration and successful quality system implementation.

Daniela Levy was a Senior Executive and Regulatory & Quality VP at Alpha Bio Tec ltd, a Dental Implants Company. During the acquisition of Alpha Bio Tec ltd by Nobel Biocare, a world leader of restorative and esthetic dental solutions, she handled the due diligence process for the support of the seller's side, Alpha Bio Tec ltd, and provided project support for the buyer side, Nobel Biocare. The process and project support were handled with good faith, fairness and loyalty for both sides.

We strive to help medical device business owners develop a solid foundation and business strategy so they can be successful. We will work to improve the company's quality targets, market targets and thus sales, safety & effectiveness.  Find out how we can help you and your business today!

Our Goal

Our goal is to improve your business's performance and comprehensive service for a successful business strategy.

Our Vision

Our Strength