Training
TRAINING AlvaMed’s approach to training sets us apart from competitors. Our training is customized to the client’s needs and delivered by regulatory, quality and clinical consultants. Our trainers are true experts in their fields and each presentation is tailored to the organization and audience. Whether it’s a general training for all your staff or a […]
MANAGING CHANGES AND MAINTAINING COMPLIANCE
Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]
UPDATES TO Q-SUB GUIDANCE PRIOR TO RELEASE OF NEW PRE-SUB DRAFT GUIDELINES
The Q-Submission Program, also known as the Pre-Submission Program, is an initiative by the U.S. Food and Drug Administration (FDA) aimed at facilitating the development and review of medical devices. It provides an opportunity for medical device manufacturers to interact with the FDA before submitting their formal applications, allowing for early feedback and guidance. The […]
FDA ISSUES GUIDANCE CONTENT OF PREMARKET SUBMISSIONS FOR DEVICE SOFTWARE FUNCTIONS
The FDA released new guidance for the Content of Premarket Submissions for Device Software Functions [1] in June 2023. This guidance replaces the preexisting guidance from May of 2005. Since then, technological advances have caused software to become an important part of medical devices. The final guidance moved to a simplified risk-based approach to determine […]
FDA ESTAR OVERVIEW
Currently, all medical device submissions for 510(k), De Novo, and Pre-Submissions may voluntarily use eSTAR. The intention of the program is to enhance the quality of submissions by providing a standardized format so submitters can ensure submissions are complete. Additionally, the review process can be streamlined and more efficient. Starting October 1, 2023, all 510(k) […]
GUIDANCE ON SIGNIFICANT CHANGES REGARDING THE TRANSITIONAL PROVISION UNDER ARTICLE 120 OF THE MDR
The European Commission published an updated Medical Device Coordination Group (MDCG) 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR in May 2023. Changes were made throughout the guidance document to align it with Regulation (EU) 2023/607 (updates to MDR/IVDR transitional provisions) and with the similar guidance document for […]
FDA’S NEW DRAFT GUIDANCE FOR HUMAN FACTORS INFORMATION IN MARKETING SUBMISSIONS
In December of 2022, the FDA released draft guidance[1] to aid medical device manufacturers in determining what information should be included in marketing submissions for medical devices using a risk-based approach. The guidance outlines how to determine a submission category, each category requires different amounts of documentation. This framework aims to improve the efficiency of FDA […]
US FAVORED OVER EU FOR MEDICAL DEVICE MARKET ENTRY
The US market has emerged as the chosen geography for market entry for new medical technology. Historically, medical device companies preferred to launch in Europe as the product registrations were perceived as more straightforward. In a survey from December 2020, the most challenging geography was identified as China and the least challenging was Europe and […]
NOT DEVICES ANYMORE: THE FDA REDEFINES SOFTWARE IN EIGHT CLASSIFICATIONS
The FDA has officially excluded certain software from the definition of a medical device (Final Rule: 86 FR 20278). Eight regulations are being amended. The classifications include Clinical Chemistry and Clinical Toxicology Devices under Part 862, Immunology and Microbiology Devices under Part 866, General Hospital and Personal Use Devices under Part 880, Obstetrical and Gynecological […]
