Qualitas Compliance LLC

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Standards

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

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About Us

Qualitas Compliance, LLC is a women owned business focused on successfully navigating the ever-changing quality and regulatory waters of the medical device industry.

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Medical Device Compliance – Charlotte

Services

Qualitas specializes in providing quality system management, compliance assistance and gap analysis in the medical device industry.  We provide services to companies throughout the USA and Canada, more recently in Raleigh-Durham-Chapel Hill, Charlotte, Atlanta, Tampa, Boston and Pittsburgh.  We are ready to help your team.

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Qualitas Compliance LLC
919-964-0939

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