Validation protocol is defined as a documented plan for testing a medical device to confirm that the production process used to manufacture the product meets the specific user, technical, and Regulatory requirements. This includes a review of process variables and operational limitations and the analysis of test results under actual use conditions.

The validation process involves several tangible actions. The steps are elucidated as follows:

An operation manual is in many ways referred to as labeling, Instructions for Use (IFU), or a user guide. It is a document that is instrumental in achieving the safety of a medical device and illustrates the general ways to use or operate a medical device.

Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.

Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).

510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices.

The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.

The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage. The newly introduced changes may alter the risk profile of the device, and the device manufacturers must revisit risk evaluations that pinpoint and reduce part or system failures over the product's lifecycle.

The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.

A change can be prompted at various stages of the medical device life cycle. Some of the common events that can act as ‘triggers for changes include the following:

Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures.

The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.