Exeed Regulatory Compliance
MARCH 22, 2020
Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic. Adverse event reporting requirements are very stringent, and late reporting of such events is a routine focus of FDA inspections and subsequent warning letters.
Hall Render
OCTOBER 5, 2023
Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. study sponsor, regulatory agencies, etc.) On August 15, 2023, the U.S.
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Exeed Regulatory Compliance
APRIL 2, 2020
Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices.
MedTrainer
JULY 12, 2023
It’s used to track, analyze, and resolve various types of incidents, including medical errors, adverse events, patient safety issues, equipment failures, security breaches, and other incidents. Incident management software enables organizations to streamline the reporting process for incidents, accidents, near misses, and other safety events.
MedTrainer
JULY 12, 2023
It’s used to track, analyze, and resolve various types of incidents, including medical errors, adverse events, patient safety issues, equipment failures, security breaches, and other incidents. Incident management software enables organizations to streamline the reporting process for incidents, accidents, near misses, and other safety events.
Dot Compliance
FEBRUARY 8, 2024
From automating critical quality processes like document control and risk management to tracking and preventing quality events, an eQMS solution streamlines these and other critical processes. The eQMS is a comprehensive digital solution that is transforming how life sciences organizations manage quality.
Dot Compliance
MAY 3, 2022
fully validated and pre-configured with best practices that meet FDA, ISO and GxP regulations. It allows anyone that provides input, reviews, manages or is responsible for changes for any quality events – from product managers to executive level leaders – to access information, anytime and anywhere. MES, SQM, PLM, etc.),
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