 |
Compliance Engineering Reference Guide Index
O'Brien Compliance Management, LLC
57 Wannalancit St, Suite 10
Lowell, MA 01854 USA
Tel: 978-970-0525
Fax: 978-970-0526
Web: http://obcompman.com
E-mail: fobrien@obcompman.com
Speed Up Your Regulatory and Safety Approvals
 O'Brien Compliance Management provides global regulatory and safety compliance management services, helping clients bring safe products to market first. We specialize in risk management, and product safety of electrical medical devices and in vitro diagnostic devices using the international standards, ISO 14971, IEC 60601, IEC 61010, and IEC 60950.
Solutions ... Acceptance ... Training ...
We provide timely and cost effective solutions to your noncompliance issues including:
- Insulation diagrams to illustrate alternative strategies for complying with electric shock requirements
- Medical system requirements to integrate non-medical equipment into medical systems
- Risk management techniques to justify alternatives to consensus safety standards
 We have the stature and relationships to gain acceptance by regulatory and safety organizations.
- Secretary for IEC SC 62A, WG 17, developing IEC 60601-1, 3rd edition
- Positive relationships with colleagues in FDA, UL, ETL/Inchcape, CSA, VDE, TUV PS, TUV Rheinland, KEMA, DEMKO, SEMKO, and NEMKO
- Past senior reviewer and trainer for UL medical staff in US, Europe, and Asia
We provide the rationale behind requirements, thereby training your staff to incorporate safety fundamentals into tomorrow's designs
- UL/Quadtech instructor for safety and risk management seminars, IEC 60601, IEC 60601-1-4, IEC 61010, and ISO 14971
We'd welcome the opportunity to learn more about your firm, so that we might help you be safe to market first.
Categories this company is listed
under in the Compliance Engineering Reference Guide:
|
