Providing regulatory project management services to locally based (Israel) and overseas medical device companies.

Regulatory services offered:

* Submission of Technical Files to Regulatory Authorities -
FDA, Notified Bodies, ANVISA & Health Canada).
* Product Usability Engineering files.
* Leading biocompatibility, sterilization validation,
disinfection and cleaning studies.
* Standards monitoring service and tracking service.
* Advising and reviewing product verification and validation
protocols and reports.

Clinical Investigations
Preparing CIP, authoring study protocols, Investigator's Brochure, and Clinical Study Reports. Supporting IDE submission process. Designing economic evaluation within the CIP, to support reimbursement.

Q. A Services
*Specializing in building and providing support to ISO *****
quality systems - drafting QOPs, SOPs and staff training.
* Internal Audit Services - ISO ***** :2003.
* External audits of critical suppliers - designing audit
schedules/questionnaires & templates.
* GAP analyses, and QOP updates in order to comply with
Canadian Medical Device Regulation (CMDCAS), and
Brazilian GMP
* Training personnel via webinars on Q. S. requirements.