IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''

IEC released amendment 1 for IEC 62304 in June of 2015. The purpose of this revision was:

1. Additional requirements to address software life cycle processes specific to legacy software
2. Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis. With a strong reference for using ISO 14971 processes
3. Minor revisions to over 40% of the standard.
4. The standard has over 160 required and over 160 suggested policy, procedure, plan, record, document, audit, or review

This checklist addresses the amendment and the base standard

“IEC 62304:2015, is often confusing and laborious. This is because directions contained in the standard can seem unclear or ambiguous. To aid in determining what is actually required by IEC 62304, the experts at SEPT have produced a checklist. This checklist was prepared by analyzing each clause in IEC 62304 for key words that signify a required policy, procedure, plan, record, document, audit, or review.

This revised standards has over 160 required artifacts and over180 suggested ones. Below is a table showing the required artifacts by type.

Required artifacts

The resulting checklist then provides an easy-to-use categorized list of physical evidence against which you can audit your work products to help insure conformance with IEC 62304.

To better understand this model a user of this product should understand SEPT definition of an auditor. An auditor can be your boss, an inside auditor or an outside auditor such as the European Union, FDA or a prime contractor for your product. The checklist will give the auditor and you a common reference point in the standard (Clause number) that becomes the index point for physical evidence. If a standard calls out physical evidence more than once , such as a “training plan” it is always index to the first clause that reference the training plan This method will allow you to organize you physical evidence in a systematic manner for presentation to the auditor. This simple checklist allows you to bring the document down to simple terms that a professional lay person can understand (policy, procedure, plans, records, documents, audits and reviews).

The checklist will allow the organization to divide the compliance activity into manageable work packages such as procedures, plans, documents etc.

The checklist is available in PDF or word format. The latter format allows you to tailor the document to your business case or the media that your organization wants to use the checklist in such as excel web page format or any other end product type in order to meet compliance with the standard in the most efficient way possible.

The checklist comes with 4 hours of free consultation, from experts that have firsthand knowledge of the underlying standard, to answer questions on the standards and checklists and is valid for 60 days after purchase of the product.

This product supports these Software Engineering processes

• Acquisition
• Configuration Management
• Design
• Documentation
• Integration
• Life Cycle
• Metrics
• Quality
• Requirements Definition
• Safety
• Verification And Validation

Customers of this product:

• Absciex
• Accuracy, Inc
• Advanced Circulatory Systems Inc.
• Airstream, LLC
• American Medical Systems
• Armadeus systems
• ASMP, Russia
• Balanceback
• BD
• Biodesix, Inc.
• Biosynthetic
• Bosch
• BSD Medical Corporation
• CAO Group Inc
• Cardio Robotics
• Care Innovations
• Carticept Medical
• Cellnovo Ltd
• Ciara technology
• CIR Systems Inc
• Coltene/Whaledent Inc.
• CPI Canada Inc.
• Danev, Canada
• Deafness Bionics A/S, Denmark
• Design spring
• Diagnosys LLC
• Document Center
• Dr. Langer Medical GmbH
• DWOS, Canada
• Eckert & Ziegler BEBIG GmbH, Germany
• Electrical Geodesics Inc
• Electron, Russia
• Elman International Inc
• Fenway
• Ferno Washington
• Garrett technologies Inc
• Grahamstoney
• Gynesonics
• Haemonetics Corporation, Canada
• HistoSonics
• Iking Systems
• Industry Technology Research Institute
• Informed SA, Switzerland
• InTouch Health
• iRobot Corporation
• ITC Engineering Services
• KTLl, RE. South Korea
• Laborie Medical Technologies Inc., Canada
• Life Scan
• Life Watch Services
• Live, Aruba
• Logics
• Medela Inc.
• Micronics, Inc.
• Minnetronix
• Mobidilag Ltd.
• Natus Medical
• NeoSoft LLC
• Nine Point Medical
• Novartis
• OCubes, Belgium
• ODEVIS AG
• Omnyx
• OptiMedica Corporation
• OrthAlign
• Pacific Biosciences
• Parker
• PCI
• Performance Controls
• PerkinElmer
• Pgxlab
• Phonak Acoustic Implants, Switzerland
• Photo Detection
• PLC Medical Systems, Inc.
• PTW Freiburg GmbH
• QIAGEN Inc.
• Qmiteam
• Radiometer Medical ApS, Denmark
• REGSolutions, LLC
• Repap Systems India Pvt. Ltd
• RMD Instruments
• Salt Creek Medical
• Sandstone Medical Technologies, LLC
• SciBase AB
• SEDECAL
• Signet Medical Systems
• Solution Link
• Sorin Group Canada Inc
• Spaulding Clinical Research, LLC
• Spinode Consulting
• St Jude Medical
• Stratford Medical LLC
• Surewest, Switzerland
• Synapse biomedical
• Synvasive Technology, Inc
• Tactile Systems
• Tecan, Australia
• Technology Association South Korea
• Tecno-Med Ingenious
• Terumo Cardiovascular Systems
• TERUMO Corp
• Thermo Fisher Scientific
• TOTOKU Electric Co., Ltd.
• Tympany, LLC
• ULTRASONIX MEDICAL CORPORATION
• Unilife Medical Solutions, Inc.
• Valueone consulting
• Verity Medical Ltd
• View Ray, Inc.
• Vital Images, Inc.
• Voalte
• Wetsco, Inc
• Xoran Technologies, Inc
• Yberonics, Inc.

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”