Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers […]

Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality. The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance […]

The Ultimate Guide To Design Controls For Medical Device Startups

    What’s this guide about anyway? Back in 1998, I started my career as a medical device product development engineer. At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general. In those days, we all struggled to understand how and what […]

Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of […]

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 […]

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

  Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect […]

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances. Medical Device Reporting Medical Device Reporting and handling of recalls are very important to the medical […]

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances. Medical Device Reporting Medical Device Reporting and handling of recalls are very important to the medical […]