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About OBCM

Overview

O'Brien Compliance Management (OBCM), located in Chelmsford, MA, was founded in April 2004 by Frank O'Brien to provide medical device manufacturers with global regulatory and safety testing, consulting, and training services.  For additional details, see our Services page.

Quality & Competency

This information provides details about OBCM, and facilitates qualification of OBCM as supplier of product safety testing, consulting, and training services. Included are details about our staff's experience and training, quality management system, and laboratory capabilities.  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'll make reasonable accommodations.  For example, customers are welcome to supervise or witness testing.

Our People

Matt, Frank, Chris, Pooja

Our Quality Management System

• 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 001, Application of Uncertainty of Measurement to Conformity Assessment Activities in the Electrotechnical Sector.

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Our Data Acceptance

TUV Partner Test Laboratory

We are an accredited Partner Test Laboratory for TUV Rheinland, allowing tight and cost effective integration of our test services into their US and Canadian certification services (OSHA NRTL and SCC).  OBCM's TUV PTL Certificate to IEC 17025 is on the Lobby Wall.

TUV Rheinland is an excellent source for US and Canadian certifications, as they're also a well respected certifier of regulatory quality management systems for the European Union and Canada.  They are a 3rd party reviewer for FDA 510(k) reviews.  We feel TUV Rheinland offers an excellent one-stop service package for medical device manufacturers.

UL Witness Testing

Tests conducted at OBCM and witnessed by engineering staff of Underwriters Laboratories (UL) 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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Our Test Capabilities

OBCM can perform product safety testing within the scope of the following product safety series of standards:

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

Our focus is testing of medical devices and in vitro diagnostic devices.  We perform IEC 61010 and IEC 60950 testing beyond this scope only when it's related to a medical or IVD system, or under special arrangement.

We are well able to conduct IEC 60601-1:2005, 3rd edition testing, as our founder has been part of the committee who drafted this edition.  We can conduct gap analysis and test reports for legacy devices.  Or we can conduct simultaneous 3rd and 2nd edition test reports for new devices.  While Canada will be requiring 3rd edition compliance in Jun 2012, and it appears European will also be at or close to this date,  other parts of the world will still be requiring compliance with 2nd edition.  Because of our partnership status with TUV Rheinland we stay up to date on how test laboratories will be assessing and documenting compliance with risk management, usability engineering, and software development.  It appears test laboratories will be having the manufacturer fill out checklist type reports of their relevant procedures and records.  The test laboratory will perform a check of these forms.

With IVD equipment, we can conduct assessments and testing to IEC 61010-1, including the particular for IVD devices, IEC 61010-2-101.  Because of our experience with medical devices, we are well able to help with risk management, usability engineering, and new software development requirements (ISO 14971, IEC 62366, and IEC 62304).  The later 2 of which are already on the harmonized standard list for Europe, and will be in the new -2-101 particular, aligned with the new general -1, 3rd edition.

We wouldn't normally conduct IEC 60950 investigations, but where it's needed for expediency purposes, we can assess and test to , IEC 60950:1999, 3rd edition (not encouraged); IEC 60950-1:2001, 1st edition; or IEC 60950-1:2005, 2nd edition.

A detailed list of the safety standards we'll test to is here (pdf file).  Also included are some rough estimates for our fees.

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Our Equipment

Our test equipment includes for general safety testing: 5 kVA, 0-280 V, 60 Hz power source 2.5 kVA, 0-280 V, 50-400 Hz power source Environmental chamber, 8 ft3, -41 C to 190 C, 5 to 95 %RH Oscilloscope, 500 MHz, 5 GS/s, with probes for 40 kV, to uV, nom. 60 Hz V and I, 500 MHz V, 60 MHz I, and differential V Electrical Multimeters Temperature Meters, ample Type K Thermocouples Dielectric Voltage Tester, 5000 Vac, 6000 Vdc Ground Impedance Tester, 45 A Defibrillation simulator, 5 kVp, 360 J Force Gauge, 250 kg Torque Meter, 15 kgcm 50 mm, 1 kg impact ball Ball pressure apparatus IPx1 or 2 drip apparatus, IPx7 or 8 submersion apparatus Peristaltic pump Time and Environmental Meters Distance measuring devices Weight scale, 68 kg Light meter, lux Sound Meter, dBA

Lab area with specialized safety test equipment

For patient monitoring safety and performance testing: Abitrary function generator and ECG simulation circuitry Pulse Oximeter simulator Noninvasive blood pressure simulator Refrigerated circulating bath, 6 L, -25 to 150 C 400 W, 2x 0-30 Vdc, 6 A; 5  Vdc, 5 A power source For HF generator and accessory safety testing: 300 VA, 400 kHz, HF surgical power supply, max 9000 Vpp, crest factors 1.4 to 8,  HF noninductive resistive loads, 10 to 50 kOhm, for up to 250 W Loading for abnormal output testing of isolation transformers and power supplies: Up to 5 kVA in ac resistive loads 3x dc resistive loading, 0.1 to 600 Ohm, for up to 2 kW All test equipment is state of the art, purchased new, and maintained with annual calibrations by an accredited IEC 17025 calibration service.

Chris enters a profile into the Environmental Chamber

We have 350 ft2 laboratory with 100 A service.  We have 350 ft2 of additional office space.

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Testing by Sub-Contractors

We have relationships with suitable local test laboratories for when shock, vibration, large scale mechanical testing, air pressure, liquid ingress IPx3-x6, dust ingress, IP5y-6y, EMC, or ultrasound acoustic thermal energy testing is necessary.  These laboratories are referenced on our Links page.  We can refer you directly to them, or at your request, we can include this testing in our test reports, as having been performed under our quality system control.  Any sub-contracted testing is declared in quote.  Our test reports indicate the test site of all testing.

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Testing at Manufacturer's Premises

If you're located within 2 hours of Boston, we can bring our power regulation, loads, and calibrated test equipment to your facility.  We'll need a suitable 208 or 240 V, 60 Hz, minimum 15 A power source, or more. if appropriate for your equipment.  We have miscellaneous plug caps for connecting to any 1 or 3 phase receptacle.  We have suitable extension cords, and power taps.  We perform the necessary validation of the power source.  

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Our Test Reports

Test methods and results professionally documented with photos, temperature charts, and oscilloscope screen shots; and where compliance is found, Certificates of Compliance.

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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