{"id":6036,"date":"2018-05-05T03:03:40","date_gmt":"2018-05-05T03:03:40","guid":{"rendered":"https:\/\/www.eisnersafety.net\/?page_id=6036"},"modified":"2025-09-03T10:13:24","modified_gmt":"2025-09-03T10:13:24","slug":"resources","status":"publish","type":"page","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/resources\/","title":{"rendered":"Resources"},"content":{"rendered":"

This page includes some of our favorite links we find useful in our everyday\u00a0regulatory & compliance work.\u00a0 Please contact us<\/a> with any suggestions for additional links or if you find any broken links. We hope you find these resources helpful.
\n<\/a><\/p>\n

Link Subjects (Jumps to Links Page):<\/h5>\n
\n

Certification Safety Agencies<\/a>
\nThird Party Test Houses<\/a>
\nStandards Organizations<\/a>
\nStandards Sales Organizations<\/a>
\nRegulatory Agencies<\/a>
\nCertification Databases<\/a>
\nTest Equipment Suppliers<\/a>
\nRegulatory Resources<\/a><\/i>
\nAdverse Incident Reporting Databases \u2013 Medical Devices<\/a><\/span>
\nBiocompatibility, Toxicity, Sterilization Testing<\/a><\/span>
\nCompliance Resources<\/a><\/p>\n<\/blockquote>\n

Certification Safety Agencies<\/h5>\n

These agencies provide a variety of services such as safety testing & certification services, EMC testing, CB scheme certification, EU MDD\/AIMDD\/IVD\/ Notified Bodies, MDR\/IVDR Designated Bodies, and Quality Management Certification.\u00a0 Most links point to the Medical Device area of the organization.<\/p>\n

Bureau Veritas<\/a>\/Curtis Straus
\n<\/a>CSA Group\u00a0\u00a0<\/a>
\nIntertek (previously ETL & SEMKO)<\/a>
\nNemko<\/a><\/a>
\nTUV SUD America
\n<\/a>TUV SUD Canada<\/a>
\n<\/a>UL<\/a>
\neurofins MET Labs<\/a>
\n<\/a>TUV Rheinland<\/a>
\nBSI (US)<\/a>
\nVDE Testing & Certification<\/a><\/p><\/blockquote>\n

Third Party Test Houses<\/h5>\n

Independent third party test houses that we have worked with to help our clients thru the Safety testing\/certification &\/or EMC testing process<\/p>\n

Medical Equipment Compliance Associates (MECA)<\/a>
\nG&M Compliance<\/a>
\nElement EMC Testing<\/a> (Previously NorthWest NorthWest EMC)<\/span>
\nCKC Laboratories<\/a>
\nOBrien Compliance Management<\/a> (Sold off test house – training only – We also offer training)<\/span>
\nNTS<\/a>\u00a0(Previously called Elliot Labs)<\/span><\/a><\/p><\/blockquote>\n

Standards Organizations<\/h5>\n

IEC<\/a>
\nISO<\/a>
\nCENELEC<\/a>
\nCEN<\/a>
\nAAMI<\/a>
\nANSI<\/a>
\nASTM<\/a>
\nNational Fire Protection Association (NFPA)<\/a>
\nFCC<\/a>
\nFCC Search Tools<\/a>
\nBSI<\/a>
\nUL
\n<\/a>CSA
\n<\/a>Japanese Standards Association (JSA)<\/a>
\nStandards Administration of China (SAC)<\/a>
\nJapan Quality Assurance Organization (JQA)<\/a>
\nVDE<\/a>
\nNational Institute of Standards & Technology (NIST)<\/a>
\nNIST – Standards & Technical Regulations<\/a> – Great Resource!<\/a><\/p><\/blockquote>\n

Standards Sales Organizations<\/h5>\n

TechStreet
\n<\/a>Document Center, Inc.
\n<\/a>IHS
\n<\/a>AAMI Store
\n<\/a>IEC Webstore
\n<\/a>ISO Webstore<\/a>
\nANSI Webstore<\/a>
\nBSI Webstore<\/a>
\nASTM Webstore<\/a>
\nNFPA Catalog<\/a>
\nComm 2000 (UL standards)<\/a><\/a><\/p><\/blockquote>\n

Regulatory Agencies<\/h5>\n

FDA (US) <\/i><\/a>
\nDevice Advice<\/a>
\nMedical Device Guidance Documents<\/a>
\nRecognized Consensus Standards<\/a>
\nCode of Federal Regulations – CFR Title 21<\/a><\/span>
\nOSHA Nationally Recognized Testing Labs (NRTL) Program<\/a>
\nHealth Canada <\/i><\/a>
\nTherapeutic Products Directorate (TPD)<\/a><\/span>
\nEuropean Commission, Medical Device Regulatory Framework<\/span><\/a>
\nEU Harmonized Standards (MDD, AIMDD, IVDD, etc.)<\/span><\/a>
\nUK Medicines and Healthcare products Regulatory Agency (MHRA, formerly MDA)<\/span><\/a><\/span>
\nAustralian Therapeutic Goods Administration (TGA)<\/a>
\nJapan Ministry of Health, Labour, and Welfare (MHW)<\/a>
\nInternational Medical Device Forum (IMDRF)<\/a>
\n<\/span><\/span><\/span><\/span><\/a><\/p><\/blockquote>\n

Certification Databases<\/h5>\n

Resource where you can find certificates for products & components from various certification organizations<\/p>\n

UL <\/a>
\nCSA<\/a>
\nVDE<\/a>
\nIECEE CB<\/a>
\nTUV SUD (America – Previously TUV Product Service)<\/a>
\nTUV Rheinland<\/a>
\nIntertek, ETL, Semko, etc.<\/a><\/a><\/p><\/blockquote>\n

Test Equipment Suppliers<\/h5>\n

Chroma Systems Solutions<\/a> (Formerly QuadTech)
\nFluke Biomedical<\/a>
\nAssociated Research<\/a>
\nVitrek<\/a><\/a><\/a><\/p><\/blockquote>\n

Regulatory Resources<\/a><\/h5>\n
\n

Country \/ Region Regulatory Resources<\/strong><\/p>\n

Medical Device Directive (MDD) Consolidated Version<\/a> (includes revisions up to September 2007)<\/span>
\n<\/a>EC Interpretative Document on the Implementation on the MDD & AIMDD Amendment 2007\/47\/EC<\/a>
\nHarmonized Standards
\n<\/a>List of Harmonized Standards for the MDD<\/a>
\nTeam Notified Body (Team NB) Report on EU Languages for MD, AIMD, & IVD Directives<\/a> July 2007\u00a0 (Outdated but a reference pt)<\/span>
\n<\/a>Medical Device Directive Guidance Documents (MEDDEVs), Consensus Statments, & Informative Documents\u00a0<\/a>
\nNotified Body Recommendations (MDD)<\/a>
\nActive Implantable Medical Devices Directive (AIMDD) Consolidated Version<\/a> (includes revisions up to September 2007)<\/span>
\nEU Medical Device Sector Information Web Page<\/a> (includes links to new regulations, tools & db’s, news, events, contracts & grants, public consultations, publications, etc.)<\/span>
\nIn vitro Diagnostic Directive (IVDD)<\/a> (includes revisions up to September 2003)<\/span>
\nRestriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive (RoHS) (Also known as RoHS2)<\/a>
\nWaste Electrical and Electronic Equipment Directive (WEEE) Consolidated Version<\/a><\/p>\n

Adverse Incident Reporting Databases – Medical Devices<\/strong><\/p>\n

The following links can be useful for comparing your product against other reported product incidents. \u00a0Also, can be a useful tool for determining appropriateness of existing safety requirements or assessing device risks.<\/p>\n

\nManufacturer and User Facility Device Experience (MAUDE) – US FDA<\/a>
\nAdverse Incident Reports – UK MHRA<\/a><\/a><\/span><\/span><\/p>\n

Biocompatibility, Toxicity, Sterilization Testing<\/strong>
\nNAMSA<\/a>
\nNelson Labs <\/a>
\nToxikon<\/a> <\/span><\/span><\/span><\/a><\/p>\n<\/blockquote>\n

Compliance Resources<\/h5>\n

MD&DI Magazine<\/a> – Multiple articles<\/a> by Leo Eisner<\/span><\/span>
\nCompliance Engineering Magazine<\/a> –\u00a0Multiple articles<\/a> by Leo Eisner<\/span><\/span>
\nMedical Electronics Manufacturing (MEM)<\/a> – Article<\/a> by Leo Eisner<\/span><\/span>
\nChina Medical Device Manufacturer (CMDM)<\/a><\/span>
\nWorldwide mains plus & sockets (voltage & frequency info) – Wikipedia<\/a>
\nIEC Just Published(sign up for IEC news letter at bottom of page)<\/a><\/p><\/blockquote>\n

Disclaimer:<\/strong> Links to organizations found at this site are provided solely as a service to our visitors. These links do not constitute an endorsement of these organizations or their programs by Eisner Safety Consultants, and none should be inferred. Eisner Safety Consultants is not responsible for the content of the Web pages found through these links<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

This page includes some of our favorite links we find useful in our everyday\u00a0regulatory & compliance work.\u00a0 Please contact us with any suggestions for additional links or if you find any broken links. We hope you find these resources helpful.<\/p>\n","protected":false},"author":4,"featured_media":6261,"parent":0,"menu_order":9,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-6036","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/6036","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=6036"}],"version-history":[{"count":23,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/6036\/revisions"}],"predecessor-version":[{"id":8157,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/6036\/revisions\/8157"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6261"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6036"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}