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Medical Device Links
This page includes all our favorite links that we've found necessary to carry out our day to day safety compliance tasks. We hope you'll find some of these links helpful as well. Please feel free to contact us with suggestions for additional links.
Regulatory Organizations
Global Harmonization Task Force
US, Dept of Commerce, Medical Device Global Regulatory Requirements
OSHA regulations and NRTL program
European Medical Device Directives, (europa.eu, medical device sector)
- EU Harmonized Standards, (europa.eu)
- UK Medicines and Healthcare products Regulatory Agency, (MHRA, formerly MDA)
Japan Ministry of Health, Labour, and Welfare (MHW)
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Medical Device Adverse Incident Databases
While accessing device risk, or while determining the appropriateness of existing safety requirements, it can be useful to consider adverse incidents for similar products. The following links can be used to review reported adverse incidents.
US FDA - Manufacturer and User Facility Device Experience (MAUDE) Database
UK - MHRA Adverse Incident Reports
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Standards Organizations
IECEE Committee of Test Laboratories (CTL) - Decision Sheets
IHS - a one-stop source for buying standards, except AAMI
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Safety/Regulatory Certification Organizations
All these organizations offer a form of one-stop: OSHA/SCC (US/Can) accredited safety certification, IECEE CB scheme certification, safety testing, EMC testing, 510(k) third party review, EU Notified Body MDD/IVDD certification, and quality management system certification
OBCM often works with UL and TUV Rheinland. OBCM can often expedite UL or TUV Rh certification by using its safety lab, and preparing certification paper work. See our Services page for details.
UL, Boston, NY, RTP, Chicago, San Jose, other global locations
TUV Rheinland, Boston, Koeln, other locations
CSA International, Toronto
Intertek, ETL/SEMKO, Boston, Cortland
VDE Testing and Certification, Dallas, Offenbach/M
TUV Product Service, Boston, Muenchen, other locations
Curtis Straus / Bureau Veritas, Boston
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Safety Testing Laboratories
We operate a safety test laboratory. See our Services page for details.
Compliance Management Group, Safety, EMC, Environmental testing, Boston, MA
Medical Equipment Compliance Associates, LLC, Safety testing, consulting, Milwaukee, WI
NTS, Safety, EMC, Environmental testing, Boston, MA
Chomerics Test Services, Safety, EMC testing, Boston, MA
see also Certification Organizations
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EMC Testing Laboratories
OBCM subcontracts with CMG, when EMC testing is packaged with our consulting and testing services. Our EMC consultant, Jim Conrad, often works with TSS.
Compliance Management Group, Safety, EMC, Environmental testing, Boston, MA
Test Site Services, EMC testing, Boston, MA
NTS, Safety, EMC, Environmental testing, Boston, MA
Chomerics Test Services, Safety, EMC testing, Boston, MA
Core Compliance Testing Services, LLC., EMC testing, Hudson, NH
see also Certification Organizations
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Environmental Testing Laboratories
OBCM subcontracts with CMG, and Quest when Environmental testing is packaged with our consulting and testing services. CMG and Quest can also do audio output and light visibility testing related to medical device alarms.
Compliance Management Group, Safety, EMC, Environmental testing, Boston, MA
Quest Engineering Solutions, Environmental testing, Boston, MA
NTS, Safety, EMC, Environmental testing, Boston, MA
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Biocompatibility, Toxicity, Sterility Validation Testing
Toxikon, Boston
Namsa, Northwood, OH
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Acoustic Thermal Index Measurements (IEC 60601-2-37, IEC 61157)
Intertek, Jim Mack,
Boxborough, MA
Sonora Medical Systems, Longmont,
CO
Onda Corporation,
Claudio Zanelli, Sunnyvale, CA
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Certification Databases
Places to find certified components and accessories
IECEE CB certification database
TUV Rheinland certification database
TUV SUD Product Service certification database
Intertek, ETL, Semko, Warnock Hersey certification databases
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Test Instrument Suppliers
Newark InOne (general supplier of Tektronix, Fluke, Agilent, Superior, Sola/Hevi-Duty, Weller equipment, and many others)
Quadtech (excellent dielectric strength, earthing, and leakage current meters)
M & S Elektronik (excellent defib-proof tester)
Elgar/Sorensen (excellent variable voltage and frequency power supplies)
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Device Safety Consultants
We provide safety consulting services, see our Services page for details.
The following are consultants with whom we sometimes work together. We can recommend all. All are expert, responsive medical device compliance specialists. We've included the name of the principal, and the office location.
Medical Equipment Compliance Associates, LLC, Brian Biersach, Milwaukee, WI
Strategic Device Compliance Services, Mike Schmidt, Cincinnati, OH
Eisner Safety Consultants, Leo Eisner, Portland, OR
MedApprove, Jim & Penny Greco, Kittery, ME
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EMC Consultants
Conrad EMC Consulting, James Conrad, Hamilton, MA
Jim is the convener of IEC SC 62A, Working Group 23, responsible for general electromagnetic compatibility requirements for medical electrical equipment. Jim has access to a test facility with full EMC testing capability. Jim is who we recommend for all EMC needs.
Should you already have an EMC test laboratory, but they are unfamiliar with determining and verifying essential performance, OBCM can help with this. See our Services page.
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Regulatory and Quality Management System Consultants
All these consultants are local to Boston, have over 20 years experience, and we recommend whole heartedly for all 510(k), PMA, Type Exam, and Quality System needs.
Should you already have a Quality System/Regulatory staff member/consultant, but time is a factor, OBCM can help with preparations for 510(k) submittals, and EU MDD/IVDD audits. See our Services page.
Chas Burr Q/R Services, Chas Burr, Winchester, MA
cGMP Services, Bill Hillenberg, Westford, MA
MedApprove, Jim & Penny Greco, Kittery, ME
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Bio Consultants
Microbiology Research Associates Inc, James Barbato, Acton, MA
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Technical Documentation Consultants
Cedarwood Associates, Michael O'Steen, Boston, MA
Michael has helped a number of OBCM customers with drafting instructions for use and other technical documentation.
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General Regulatory and Compliance Resources
Worldwide mains plug & socket, and voltage & frequency information at Wikipedia
- MD&DI Magazine
- ITE Power Supplies and Medical Equipment, by Frank O'Brien, president of OBCM, Feb 2000
- A New U.S. National Standard for Medical Devices, co-authored by Frank O'Brien, president of OBCM, Sep 2006
Compliance Engineering Magazine
- What's New in EMC Standards for Medical Devices, co-authored by Frank O'Brien, president of OBCM, Aug 2007
Safety Link, (International Product Safety News, Art Michaels)
BioSpace, (Information about life science industry)
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Support Groups
MedDevGroup Meetings, Boston Area
Northeast Product Safety Society, Boston Area
Massachusetts Medical Device Industry Council (MassMEDIC), Boston area
Merrimack Valley Venture Forum (MVVF), Boston area
Massachusetts Medical Device Development Center (M2D2), UMass Lowell, UMass Worcester, Boston area
Advanced Medical Technology Association (AdvaMed), (formerly HIMA), Washington DC area
Regulatory Affairs Professional Society, (RAPS), Washington DC area
OBCM Annual Gathering
OBCM and Frank O'Brien have an annual Saint Paddy's Gathering for customers and friends. It's held every year on the Saturday on or before Saint Patrick's Day (17 March). Our staff looks forward to greeting you. For additional details, see here.