Qualitas Compliance can help keep you up-to-date with the latest medical industry standards. Qualitas Compliance can conduct gap analysis to the standards listed below to ensure your company is meeting all of the necessary requirements. In addition, we can assist with the implementation of the various standards / processes within your Quality Management System and device records. We can also help you conduct a design review specific to a particular standard.
| Standard | Description |
|---|---|
| ISO 13485:2016 | Medical Devices—Quality Management Systems Requirements—Requirements for Regulatory Purposes. |
| ISO 9001:2015 | Quality Management Systems Requirements Standard |
| ISO 10993 | Biological Evaluation of Medical Devices |
| ISO 14971:2012 | Medical Devices-Application of Risk Management to Medical Devices (BSI Standards Publication) |
| ISO 15004:2007 | Ophthalmic Instruments-Fundamental requirements and test methods |
| ISO 9022-2:2002 | Optics and optical instruments-Environmental test methods |
| IEC60601-1: ED 3.1 2012 | Medical Electrical Equipment-Part 1: General Requirements for the Basic Safety and Essential Performance |
| IEC60601-1-2 Ed. 3.0 2007 | Medical Electrical Equipment-Part 1-2: General Requirements for the Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility-Requirements and Test |
| IEC62304:2006 | Medical device software – Software life cycle processes |
| IEC60601-1-6: Ed. 3.0 2010 | General Requirements for the Basic Safety and Essential Performance—Collateral Standard: Usability |
| IEC60601-1-8: Ed. 2.0 2006 | General Requirements, test, and guidance for alarm systems in medical electrical equipment and medical electrical systems. |
| IEC 60601-1-11 :2010 | Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. |
| IEC60601-2-10: Ed 2.0 2012 | Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators |
| IEC60601-2-22: Ed. 3.0 2007 | Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC60601-2-24: Ed. 2.0 2012 | Particular Requirements for the Basic Safety and Essential Performance of Infusion Pumps and Controllers |
| IEC 60601-2-50: Ed. 2.0 2009 | Particular Requirements for the Basic Safety and Essential Performance of Infant Phototherapy Equipment. |
| IEC 60601-2-52:2009 | Particular Requirement for the Basic Safety and Essential Performance of Medical Beds. |
| IEC 60601-2-57:2011 | Particular requirements for the basic safety and essential performance of non laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/asesthetic use |
| IEC 62366:2007 | Medical Device—Application of Usability Engineering to Medical Devices |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| IEC 61326-1 Ed 2.0 2012 | Electrical equipment for measurement, control and laboratory use EMC requirements. |
| IEC 61326-2-6 Ed 2.0 2012 | Electrical equipment for measurement, control and laboratory use – EMC requirements Part 2-6: Particular requirements- Invitro diagnostic (IVD) medical equipment |
| IEC 60695-2-10: 2013 | Fire hazard testing Glowing hot wire based test methods |
| IEC 61010-2-81: 2001 | Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
| IEC 62474: 2012 | Material declaration for products of and for electrotechnical industry |
| IEC 62321: 2008 | Electrotechnical products- Determination of level of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) |
| EN50581: 2012 | Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances |
Is your medical device ready to meet RoHS compliance?
Qualitas can work with you to prepare your technical files for compliance.
Helpful Links: FDA and Medical Device Industry