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About OBCM

Overview

O'Brien Compliance Management (OBCM), located in Lowell, MA, was founded in April 2004 by Frank O'Brien to provide medical device manufacturers with global regulatory and safety consulting, testing, and training services.

Quality & Competency

This information provides details about OBCM, and facilitates qualification of OBCM as supplier of product safety consulting, testing and training services. Included are details about laboratory capabilities, quality management system, and staff experience and training.  Normally a copy of this information can be filed in a supplier folder for OBCM; to serve as objective evidence to internal or external quality system auditors that OBCM has suitable quality and competency to provide product safety related services.  Should your qualification process include the need to audit our operations, we are happy to accommodate this.

General Supplier Information

We're happy to complete any supplier/vendor qualification forms you may have.  Information that may be of use:

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Test Capabilities

OBCM maintains facilities and equipment to allow complete product safety testing within the scope of the following product safety series of standards:

• IEC 60601, Electrical Medical Equipment;
• IEC 61010, Electrical Equipment for Measurement, Control, and Laboratory Use; and
• IEC 60950, Information Technology Equipment

Capabilities include:

• Ac power capability, 85-280 Vac, 1 phase, 45-500 Hz, 2.5 kVA, (60 Hz, 5 kVA).
• Defibrillation simulator, +/-5 kVp, 400 J.
• ECG cardiac signal simulator, 1 mVpp, 1-10 Hz, with or without variable +/-5 Vdc component
• Dc power capability, 5-12 Vdc, 250 W.
• Ac resistive loading, 240 Vac, 45-500 Hz, 0.1-5 kVA.
• Non-inductive resistive loading for rf sources, 0.01-50 kOhm, 50-250 W.
• Dc resistive loading for 0.1-600 Ohm, 20-2000 W, typically 3 outputs simultaneously.
• Overhead fan hood for venting any smoke from abnormal testing
• Water supply and drain hookup.
• 0.9% saline, in stock.
• Water ingress equipment, IPx1, x2, x7, x8.
• All electrical, mechanical, thermal, and liquid test and measuring equipment is state of the art, fully calibrated.
• Test methods and results professionally documented with IECEE CB Scheme Test Report Forms, including photos, temperature charts, and oscilloscope screen shots; and Certificate of Compliance.
• Guest desk, computer, and sitting area for customers who want to witness or supervise testing.
• Test equipment is fully portable, so can be used at your facility.
• All testing conducted by an expert who's been testing medical and IVD devices to international requirements since 1980.

Any Humidity, Oven conditioning, Vibration, Environmental, or EMC testing is sub-contracted to a suitable local test laboratory under the quality system control of OBCM.  Any sub-contracted testing is declared in quote.

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Data Acceptance

Test Reports and Certificates of Compliance issued by OBCM are considered part of your verification documentation for FDA approvals/clearances, CE Marking declarations, and other 1st-party declarations to customs officials, regulators, and customers, provided OBCM is accepted by your supplier qualification process, as a competent test laboratory for device safety requirements.  Quality and competency criteria should include that OBCM operate under a quality management system in compliance with ISO/IEC 17025, and have staff with suitable experience and training.

TUV Partner Test Laboratory

OBCM is certified by TUV Rheinland to ISO/IEC 17025 and the TUV Partner Test Lab (PTL) requirements, for product safety testing to IEC 60601-1 (for medical devices), and IEC 61010-1 (for IVD/lab equipment).  As a PTL, OBCM can handle all submittal paperwork, including the submission of test data, for TUV Rheinland's review and audit; thereby efficiently integrating TUV's certification processes into OBCM's testing and reporting processes.  OBCM's TUV PTL Certificate is on the Lobby Wall.  TUV Rheinland engineering staff are located within an hour's drive of OBCM.

UL Witness Testing

Tests conducted at OBCM and witnessed by engineering staff of Underwriters Laboratories are routinely used for fulfilling UL's US and Canadian certification programs.  UL engineering staff are located within an hour's drive of OBCM.

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Quality Management System

OBCM operates under a Quality Management System in compliance with the following requirements:

• ISO 9001:2000, EN ISO 9001:2000, Quality management systems -- Requirements;
• ISO/IEC 17025:2005, EN ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories;
• IECEE 02, Scheme of the IECEE for Mutual Recognition of Test Certificates for Electrical Equipment (CB Scheme) - Rules of Procedure; including reference documents:
• IECEE-CB-Scheme Operating Documents (ODs) pertaining to CB Testing Laboratories (CBTLs), including OD-CB2012, 2015, 2017, 2020, 2022, 2024, 2027, 2028, 2030, 2031, 2032, 2033, 2040;
• IECEE-CB-Scheme CTL Operating Procedures (CTL-OP), including CTL-OP100, 101, 103, 107, 108, 109;
• IECEE-CB-Scheme, CTL Decision Sheets (CTP-DSH), including those pertaining to Generality, (including Measurement accuracy and tolerances, 251A), IEC 60601-1, IEC 61010, IEC 60950; and
• IECEE-CB-Scheme, CTL Guide 100, Application of Uncertainty of Measurement to Conformity Assessment Activities in the Electrotechnical Sector.

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Biographical sketch of staff

Frank O'Brien

Prior to forming OBCM in April 2004, Frank was a Manager and Senior Staff Engineer at Underwriters Laboratories, where he worked for 24 years.  Although Frank spent a good portion of his career within the "ivory towers" of Underwriters Laboratories, he maintains a pioneering spirit as a result of spending most of those years developing new businesses for UL. For this reason, Frank brings a unique blend of global, business development, technology, and regulatory perspectives to a design team. Frank has a consistent track record of recognizing trends, finding the proper balance among sometimes conflicting priorities, and motivating people to work towards a common set of goals.

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Global expertise

Frank has worked with medical device manufacturers and test laboratories from all over the world. Frank has lived in Melville, NY; Frankfurt, Germany; Santa Clara, CA; and his current home in the Boston area.   While in Germany, Frank served medical device manufacturers from all over Europe.  While in Santa Clara, Frank served medical device manufacturers on the West Coast and the Pacific Rim.  Throughout his career, Frank has traveled extensively throughout the world.

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Business development expertise

As Section Manager of Medical Device Services, Frank tripled UL Santa Clara's medical device services revenue over a 3-year period, from $0.46 to 1.5 million by implementing customer focused processes for delivering international IEC 60601 test services, with a CB compliance document as the deliverable, and encouraging staff to cross sell new medical regulatory related services. He set up new medical device operations in Boulder, CO, and Brea, CA; and led the corporate development effort for a medical device services brochure. Santa Clara went from being UL's 4th largest office in revenue and certifications to being the largest.

Prior to Santa Clara, Frank was UL's first European manager, growing certification operations from startup to $1 million in 6 years.  He led UL's efforts nurturing relationships with other test houses, including VDE, TUV PS, KEMA, SEMKO, DEMKO, NEMKO, IMQ, LCIE, and LGAI. He managed staff responsible for safety of medical devices, information technology, industrial control, lighting, and appliance categories.

Over his career Frank has helped many startup firms get new products to market, particularly in Silicon Valley and Boston.

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Technology expertise

Frank has worked with 1000's of electrical therapeutic, diagnostic, monitoring, and in vitro diagnostic devices, covering the full breath of sizes, technologies, and clinical applications including:

According to Medical Device & Diagnostic Industry (MD&DI), July 2005, the Top 10 Technologies in medicine having the biggest effect are: 1) implantable elution devices (drug assisted stents), 2) carotid artery stents, 3) heart assist devices, 4) artificial bone and skin drafts, 5) artificial orthopedic disks, 6) nucleic acid-based IVD's, 7) medical lasers, 8) medical imaging technology, 9) wireless technology, and 10) computer-assisted surgery.

Of these 10, 6 involve electrical medical device technologies. OBCM has clients working in 5 of the top 6:

• Thoratec makes heart assist devices, (LVAD's),
• BioScale and HistoRX make nucleic acid-based IVD's,
• Medtronic Navigation (formerly Breakaway Imaging) provides real-time CT type imaging during surgery
• Smith & Nephew makes wireless and voice recognizing operating room control systems
• MAKO Surgical makes computer assisted surgical equipment

OBCM is also working with Kensey Nash and Novelis on innovative alternatives to clearing artery blockage.  OBCM is working with Boston Scientific, and Mitralign on innovative minimally invasive surgical devices.  Prior to forming OBCM, Frank O'Brien has worked with laser manufacturers, Laserscope and Coherent.  Frank was also instrumental in Intuitive Surgical receiving their US and European regulatory approvals on their ground breaking computer assisted surgical device, the da Vinci.

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Regulatory expertise

Frank's expertise with international regulatory systems and standards includes: Risk management (ISO 14971), safety of medical devices (IEC 60601), safety of laboratory and IVD devices (IEC 61010), safety of information technology equipment, (IEC 60950), medical regulatory quality systems (ISO 13485), the EU Medical Device Directive (MDD,  93/42/EEC), EU In Vitro Diagnostic Directive (IVDD, 98/79/EC), Canadian Medical Devices Conformity Assessment System (CMDCAS), and FDA 510(k) reviews

Frank is also an expert with the qualification requirements for testing facilities, including the laboratory quality system requirements in ISO/IEC 17025.  Frank helped GE, Milwaukee receive Supervised Manufacturer's Testing accreditation from UL, under UL's IECEE CB Scheme accreditation, allowing GE to submit data to UL for audit, rather than 100% witnessing.  While with UL, Frank was responsible for gaining accreditation from the IECEE CB scheme in the medical sector for UL Santa Clara, and UL Boston.

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Groups and Associations

Frank is currently an expert member of IEC SC62A/ISO TC121, Joint Working Group 6, drafting new requirements for IEC 60601-1-11, for home healthcare equipment.  He is a member of SC62A, Convener Advisory Group, which is responsible for the 3rd edition of IEC standard 60601-1:2005, electrical medical equipment, basic safety and essential performance.  He was secretary of IEC SC62A, Working Group 17, responsible for formulating the mechanical requirements for the 3rd edition of IEC 60601-1:2005.

Frank is member of ANSI, AAMI, RAPS, and IEEE.

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Teaching expertise

OBCM currently offers training courses to IEC 60601-1, 2nd & 3rd editions.  Prior to 2007, Frank was contracted by UL/Quadtech to provide instructor services for their medical device safety training seminars.  Prior to forming OBCM, Frank was the key developer, and instructor for UL's medical device safety training seminars.

Frank was a senior reviewer and trainer for UL medical staff in the US, Europe, and Asia.  Frank frequently speaks at industry conferences, (News), including IEC, AAMI, MassMedic, MD&M, and has published articles in Medical Device & Diagnostic Industry (MD&DI), Feb 2000, and Sep 2006; and Conformity magazine, Aug 2007.

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Educational Degrees and Certificates

Frank has an MS degree from Stony Brook University in Technology Management, including MBA courses macro economics and financial accounting, and a BS degree from Clarkson University in Electrical and Computer Engineering.

Frank is a Professional Engineer in New York State.

For those who like to read plaques on lobby walls, here are Frank's degrees and certificates.

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Chris Studley

Chris Studley is an Associate Project Engineer, helping our medical device manufacturing customers with their testing, report writing, and general compliance management tasks.  Prior to joining OBCM in August 2007, Chris worked 6 years in the Research & Development departments of a number of Boston based medical device manufacturers, including Medtronic Navigation (formerly Breakaway Imaging), Cynosure, Seacoast Technologies, and GE Medical (formerly VTI).

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Anissa Herrick

Anissa Herrick is an Account Executive, providing customer support, including requests for quote, project management and invoicing.  Prior to joining OBCM in December 2007, Anissa worked 13 years as an Account Manager and Engineering Team Leader for Intertek and TUV Rheinland.  She is an expert in assisting medical device manufacturers with global regulatory requirements.

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Employment Opportunities

Join the team at OBCM.  We work with medical device manufacturers who are developing the world's next medical device breakthroughs.

Associate Project Engineer, Project Engineer, Senior Project Engineer

Applicant should have experience with power or electronics, and at least a high school degree with two years experience, or an Associates Degree.   Prior experience with testing to any international safety standard desirable.  Position requires working with customers, and customers' suppliers to test a medical device for compliance with product safety standards, (i.e. IEC 60601-1), and to document compliance.  Familiarity with MS Office is required; familiarity with Adobe Acrobat Professional and Photoshop desirable.  Some travel may be required.

Work environment provides state-of-the art test equipment and work stations.  You'll be working under one of the world's foremost experts for medical device safety; providing a very good learning environment.  OBCM offers competitive salary and benefits package, including health care insurance.  Interested applicant should submit cover letter and resume to Contact Us.

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