Company Profile

Eisner Safety Consultants  (ESC) is a network of experienced professionals assembled to provide support to the medical device, in-vitro diagnostic, and other high tech electronic device companies.  We offer assistance with your European CE Mark, US and Canadian regulatory needs.  Specialties include product evaluation to safety standards, Agency coordination, Quality Systems, CE Mark and training.  All of our associates have more than 15 years of experience working in both international regulatory agencies and industry.  This way we can provide answers to the regulatory issues, while practically fitting your business needs.

We are headquartered in Santa Barbara, California, but have associates located throughout California and the United States.  Our associates can come to your location, or in many cases provide support via phone, facsimile, e-mail, overnight delivery services, and the internet.

Product Safety 

All too often the electrical safety of a device is left to the end of the design phase.  The staff of ESC consists of experts who have worked at some of the premier National and International Safety Agencies.  They have the inside knowledge to help you successfully through the regulatory process.  The electrical safety of your device or component is all too often left to the end of a project.  Let ESC work with you to insure that the safety requirements of the appropriate U.L., CSA, EN, and IEC standards are designed into your product. We can function as a part of your design team, and save you time and money when the time comes for submission of your product for approval. 

CE Marking 

Need a technical file or design dossier for a product covered under one of the many European Directives including the Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), low Voltage Directive (LVD), or EMC Directive?  The staff of ESC consists of experts who have worked at some of the European Unions leading notified bodies. This inside expertise can assist you in understanding the requirements of the many EU directives that may impact your products.  Support is available to integrate the needed CE Marking procedures into your system.  ESC can prepare or review your technical files and design dossiers to assure that you comply with the applicable essential requirements for your product. 

Quality Systems/ISO 9000

Our services range from establishing a full documented quality system for CE Marking to updating a previously GMP compliant system to meet the new FDA QS Regulation (QSR).

Sterilization

Do you need to provide sterile products, but do not have the expertise to address the validation requirements?  Today’s cost consciousness makes it difficult to maintain in-house expertise in medical device sterilization.  ESC can provide the support you need to assure that this important process is properly validated to the latest U.S., and international standards.

Training

Even the best outside support requires that your staff be able to support you in the long term.  See how ESC can support your training needs and assist in maintaining the systems within your company.  ESC offers custom training programs on the following topics. 

• Product Safety to EN60601-1 or EN61010-1 and UL, CSA, IEC standards

• CE Marking of Medical Devices, IVDs, and per the Low Voltage Directive

• ISO 9000/EN 46000/ISO 13485/QSR

• Quality System Auditing

• Risk Analysis and FMEA

• Sterilization validation and methods