Items Tagged with 'regulations'

From a regulatory standpoint, progress in medical device development is measured by evidence, not by phase completion.

Are your vendors adhering to the latest industry standards?

Quality professionals regularly prepare documentation for regulators, customers, and internal auditors. 

Whistleblowers protect the public interest by exposing harmful misconduct and maintaining trust in institutions. However, they must choose their battles wisely, as they often face significant challenges. In the transportation sector, AIR21 helps safeguard their rights.

In 2025, medical device manufacturers are grappling with heightened regulatory uncertainty, leading to slower reviews and communication difficulties with the FDA. This situation drives them to reassess operations for compliance and risk management, with a strong emphasis on maintaining product quality, which is vital for patient safety.

Since the rise of additive manufacturing (AM) in the 2010s, many businesses across the world are now looking at this method of manufacturing to see where it can add benefits across the supply chain.

Standards and regulations rule the aerospace industry. Inspections and reviews are crucial to passenger and flight safety, but compliance with these standards can become time consuming and expensive. 

This spring have presented no shortage of hurdles. While many industries are facing new challenges, for those in manufacturing, this may mean continuing production despite supply chain disruptions, health and safety concerns, and economic impact.

A fundamental shift is taking place in the way companies are approaching regulatory compliance. A lack of structured data is proving to be a substantial liability—as ill-prepared companies are learning the hard way—which is leading more organizations to move away from conventional document-centric methodologies and toward a data-centered model of compliance.