1. Sterling Medical Registration
Quality & Regulatory Consulting
WWW.SterlingMedicalRegistration.com daniela@SterlingMedicalRegistration.com
Daniela Levy

2. 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

3. 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

4. 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)
1
2
3
4
5
6
7
✓
✓
8 Design & Development, incl. Risk Management ISO 14971✓
Sterling Medical Registration
Quality & Regulatory Services for Medical Devices
✓
✓
✓
✓
✓

5. 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
21
Testing Services
Product Testing Evaluation

6. 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
43
Testing Services
Product Testing Evaluation

7.  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 File
In compliance with the
Medical Device Directive
MDD/93/42/EEC
Quality System
Implementation
ISO 13485
Medical Device Marketing in the EU
CE MARKING
Sterling Medical Registration
Sterling Medical provides Authorised European Representative

8.  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 Services
ISO 13485 Medical Devices Quality System Management
Professional
ExperienceResults
And
More

9. THANK YOU!
Sterling Medical Registration
Daniela Levy
Regulatory & Quality Services
Israel Tel: 972-54-8318602
USA Tel : 1-213-787-3026
Email: daniela@sterlingmedicalregistration.com
WWW.STERLINGMEDICALREGISTRATION.COM
For further information please visit our website