EISNER SAFETY CONSULTANTS
EISNER SAFETY CONSULTANTS
3331 SW Seymour St
Portland, OR 97239
3331 SW Seymour St
Portland, OR 97239
Categories: Electromedical Equipment, Engineers Safety, Product Certification, Safety Or Performance, Quality Assurance Consultant
Eisner Safety Consultants provides medical device manufacturers regulatory support.
Eisner Safety Consultants (ESC) is a network of experienced professionals which provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device companies. We provide assistance with U.S., Canadian, European, and other international regulations. Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), and training. For further details please see our complete list of services. All of our associates have more than 20 years of experience working in both international regulatory agencies and industry. This way we can provide answers to the regulatory issues, while meeting your business needs.
We are headquartered in Portland, Oregon, but have associates located throughout the West Coast and North America. Our associates can come to your location, or in many cases provide support via web meetings, phone, facsimile, e-mail, overnight delivery services, and the internet.
Keywords: product approvals, safety, regulatory agencies, medical device, in-vitro diagnostic, U.S., Canadian, European, international regulations, 510(k)s, product safety, IEC 60601-1, UL 60601-1, CSA 60601-1, standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), regulatory agencies.
Eisner Safety Consultants (ESC) is a network of experienced professionals which provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device companies. We provide assistance with U.S., Canadian, European, and other international regulations. Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), and training. For further details please see our complete list of services. All of our associates have more than 20 years of experience working in both international regulatory agencies and industry. This way we can provide answers to the regulatory issues, while meeting your business needs.
We are headquartered in Portland, Oregon, but have associates located throughout the West Coast and North America. Our associates can come to your location, or in many cases provide support via web meetings, phone, facsimile, e-mail, overnight delivery services, and the internet.
Keywords: product approvals, safety, regulatory agencies, medical device, in-vitro diagnostic, U.S., Canadian, European, international regulations, 510(k)s, product safety, IEC 60601-1, UL 60601-1, CSA 60601-1, standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), regulatory agencies.
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Interview Q&A
How long have you been in business?
Over 10 years.
What is your primary product or service?
Regulatory consulting services for the medical device industry. It spans from product safety; EMC; risk management; quality systems; auditing; 510(k), IDE & PMA submissions; EU MDD technical files & design dossiers; to preparing Health Canada submissions
How did you first become interested in your line of business? (if owner) - What is your background? (If owner or store manager)
Have always been involved in product safety from when I was right out of college til now and this brought me into the medical device industry in '94 and I really enjoy this industry as it helps people.
How do you differentiate yourself from other businesses in your category and area?
Able to provide a wide range of services in the regulatory scheme for the medical device industry
How many locations do you have and do you have plans to expand?
Each of my associates has their own offices. Currently that is 14 offices primarily on the West Coast.
Over 10 years.
What is your primary product or service?
Regulatory consulting services for the medical device industry. It spans from product safety; EMC; risk management; quality systems; auditing; 510(k), IDE & PMA submissions; EU MDD technical files & design dossiers; to preparing Health Canada submissions
How did you first become interested in your line of business? (if owner) - What is your background? (If owner or store manager)
Have always been involved in product safety from when I was right out of college til now and this brought me into the medical device industry in '94 and I really enjoy this industry as it helps people.
How do you differentiate yourself from other businesses in your category and area?
Able to provide a wide range of services in the regulatory scheme for the medical device industry
How many locations do you have and do you have plans to expand?
Each of my associates has their own offices. Currently that is 14 offices primarily on the West Coast.
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