Medical Device Software Validation

 As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced FDA consultant can make a significant difference in your market authorization and compliance efforts. Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product. IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to comp...

 The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations.  Medical device manufacturers receive observations ( Form 483 ) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records. Some tips to avoid a warning letter and form 483 observation – ·          Be Inspection Ready ·          Clearly Written Standard Operating Procedures ·          Proper Document Control ·          Develop a Compliance Culture ·          Correct Observations Real-time ·       ...

 The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management for medical devices and steps to implement it during the product development stage . Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators, or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. Steps Involved  for Risk Management ·          Risk Management Framework & Planning ·          Risk Analysis ·          Risk Evaluation ·          Risk Control · ...

 Until today, medical devices were complying with the MDD to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2021 to comply with the new regulations. As companies plan and execute their transition projects to bring their organizations into compliance under the new Regulation, it's important to be aware of all the major changes that will require planning and action. Medical device companies are required to comply with various new / updated regulations of MDR. Many Class I medical device companies are now required to comply along with various products are reclassified and all legacy products are required to receive approval too. Typically, all MDD-MDR Tra...