Sterling Medical RegistrationQuality & Regulatory Consulting

WWW.SterlingMedicalRegistration.com daniela@SterlingMedicalRegistration.com Daniela Levy

Sterling Medical Registration

Sterling Medical Registration specializes in Regulatory & Quality consultation for Medical Devices Companies.

Sterling Medical Registration holds more than 17 years of experience in the Medical Device Field, with specialties in Dental Implant Systems.

Sterling Medical Registration range of services offer complete solutions for Quality System Implementation, Design & Development Services, Medical Devices Registration all over the world, Product Testing, Clinical Testing, Distributor Search Services, HR Services and Trade Mark & Patent Services.

Sterling Medical Registration goal is to ensure that your company and your medical devices will meet the applicable regulations and specifications.

Sterling Medical Registration will assist you to achieve your market targets. With us you can do it right from the first time !

Company Profile

Sterling Medical Registration

Regulatory Services• RA Consulting• Medical Device Registrations• Market Requirements prior to sales• Licensing Maintenance• Product Classification• Product Labeling• Medical Device Reporting Service• Import & Export Regulations• Agent Representative Services

• Representative Services• USA - US Agent• Europe – European Representative• Israel

• Patent & Trade Mark Registration• Global service

• Distributor Search• Market Requirements• Connect you with distributor which meet

your needs• Distributor Search + Report

Sterling Medical Registration

CE Marking - Medical Device Directive 93/42/EEC

Consulting Services for Production Facility Establishment

Products Registration 510K, Canada, Israel, S.America ….

Internal Audits, Quality Trainings

Quality System Implementation ISO 13485, FDA, Canada

Clinical Evaluation, Clinical Studies, PMS

Product Testing (e.g. Validation Testing, EMC, Mechanical)

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8 Design & Development, incl. Risk Management ISO 14971✓

Sterling Medical Registration Quality & Regulatory Services for Medical Devices

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Biological Evaluation for Medical Devices.

Biocompatibility Testing.

Chemical characterization of materials.

Clinical Evaluation.

Clinical Retrospective / Prospective Studies

Biological Evaluation Testing

Validation Sterilization in Gamma Ray.

Validation Sterilization in Moist heat.

Microbiological Test methods.

Packaging Validation.

Validation - Sterilization Testing

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Testing Services Product Testing Evaluation

Surface Testing:

• SEM Testing

• EDS Testing

• XPS Testing

Safety / EMC Testing

Electricity Testing

And more with accordance to the Medical Device Type.

Other Testing

Fatigue Testing for Dental Implants and Abutments.

Test Methods for Metallic Medical Bone Screws (Pull Out Testing).

Test Method for pitting or crevice corrosion of Metallic surgical implant materials.

Tensile Testing.

Peak Torque0

Arch Compression Testing.

Mechanical Testing

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Testing Services Product Testing Evaluation

ISO 13485 and EC Certificates are being issued. Mark your products with the CE MARK. Appoint your Authorised European Representative. Notification for Class I Medical Devices.

Certification Process Audit by a Notified Body

Technical FileIn compliance with the

Medical Device DirectiveMDD/93/42/EEC

Quality System Implementation

ISO 13485

Medical Device Marketing in the EUCE MARKING

Sterling Medical Registration

Sterling Medical provides Authorised European Representative

Quality System Implementation Quality System Maintenance Services GAP Analysis Services Quality Audits Quality Trainings Design & Development DHR, DMR Risk Management ISO 14971 Clinical Evaluation , Clinical Studies Customer Complaints Process & Production Control Process Validation -

o Sterilization o Packaging o Clean Room o Machinery

Sterling Medical Registration

Quality Assurance ServicesISO 13485 Medical Devices Quality System Management

Professional

ExperienceResults

And More

THANK YOU!Sterling Medical RegistrationDaniela LevyRegulatory & Quality ServicesIsrael Tel: 972-54-8318602USA Tel : 1-213-787-3026Email: daniela@sterlingmedicalregistration.com WWW.STERLINGMEDICALREGISTRATION.COM

For further information please visit our website