200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices. These are the reasons for it: Lack of proper and complete implementation and gaps […]

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

Applying ISO 14971 and IEC 62304 to medical device software

Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons: Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as […]

Risk Management Seminar for Applying ISO14971 and IEC62304

  Course “Applying ISO14971 and IEC62304 – A guide to practical Risk Management” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot […]

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies. ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for […]

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization. Part of both ISO 13485 and QMS Internal audits are required as part […]

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made: Managing risks Validation of processes Establishing product/process specifications to QC to such specifications Monitoring compliance to such specifications Lack of proper and thorough grasp of and correct implementation of […]

The ISO 13485:2016 standard is new and needs to be looked at afresh

With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although […]