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Latest News
Canada Announces 1 June 2012 Effective Date For 3rd Edition
OBCM hires new Project Engineer; Staff up to four
Speed Up Your Regulatory and Safety Approvals
O'Brien Compliance Management, (OBCM), founded by Frank O'Brien, provides regulatory compliance management services for US, European, and other international markets. OBCM helps reduce costly redesigns and approval delays by integrating regulatory safety requirements into the early phases of your product life cycle. Specialties include: Risk Management, Usability Engineering (Human Factors), Safety, Essential Performance, and EMC of electrical medical devices and in vitro diagnostic (IVD) devices. Services include: Consulting, Testing, Liaisoning Approvals, and Training. International standards routinely applied include: ISO 14971, IEC 60601, IEC 61010, and IEC 60950.
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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
- Single-fault-safe motion control systems
- Mechanical safety factors
- Risk management techniques to justify alternatives to consensus safety standards
- In-house test laboratory operating under an ISO/IEC 17025 and ISO 9001 quality system
We have the stature and relationships to gain approvals from regulatory and safety organizations.
- Secretary for IEC SC 62A, WG 17, developing IEC 60601-1, 3rd edition
- Positive relationships with colleagues in UL, ETL/Intertek, CSA, VDE, TUV PS, TUV Rheinland, KEMA, DEMKO, SEMKO, NEMKO, and FDA
We provide the rationale behind requirements, thereby training your staff to incorporate safety fundamentals into tomorrow's designs
- Provider of safety and risk management seminars, IEC 60601, IEC 60601-1-4, IEC 61010, and ISO 14971
We know your device
We've worked with 1000's of electrical therapeutic, diagnostic, monitoring, and in vitro diagnostic devices, covering the full breath of sizes, technologies, and clinical applications. For details see About Us.
We know your regulatory and product safety requirements including:
- Risk management, ISO 14971
- Safety of medical devices, IEC 60601
- Safety of laboratory and IVD devices, IEC 61010
- Safety of IT equipment, IEC 60950
- Test laboratory quality systems, ISO/IEC 17025
- Medical regulatory quality systems, ISO 13485
- EU Medical Device Directive (MDD, 93/42/EEC)
- EU In Vitro Diagnostic Directive (IVDD, 98/79/EC)
- Canadian Medical Devices Conformity Assessment System (CMDCAS)
- FDA 510(k) reviews and QSR
Our clients include some of the largest medical device manufacturers:
- Johnson & Johnson, Raynham, MA
- General Electric, Milwaukee, WI
- Siemens, Mountain View, CA
- Boston Scientific, Natick, MA
- Smith & Nephew, Andover, MA
Our clients include startups with the newest innovations:
- Breakway Imaging, Littleton, MA
- MAKO Surgical, Hollywood, FL
- HistoRX, New Haven, CT
We'd welcome the opportunity to learn more about your firm, so that we might help you be safe to market first