Patents represent rock-solid proof of ownership of an idea. And this is important because an idea is intangible. There are only two ways a court of law recognizes ownership of an idea - NDA and Patent...

From a practical standpoint, having a written agreement is a way of “vetting” the opposing side. Writing a formal agreement involves the review and assistance of legal counsel during the contract form...

It is important that you understand the terms of the agreement of NDA before signing it. NDAs generally contain a few specific pieces: Definitions of confidential information Obligations from all inv...

Most organizations have three management levels: first-level, middle-level, and top-level managers. These managers are classified according to a hierarchy of authority and perform different tasks. Mid...

Abraham Maslow, a psychologist from the behavioral era of management history, proposed a theory of motivation based on universal human needs. Maslow believed that each individual has a hierarchy of ne...

It is interesting that you pointed out how we're working in martix type organization. Our team has the first meeting on last Friday and we have decided to keep Fridays fixed for our weekly meeting. A...

To make sure medical devices remain safe and effective once it’s on the market - medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the mar...

SWOT analysis is one of the techniques organizations use for risk management of their products. SWOT stands for Strengths Weaknesses, Opportunities, and Threats. The organizations employ the SWOT anal...

As of now, governments do not have own guidelines for performing risk management. They refer to ISO 14971, the global standard for medical device risk management. The intent of the standard is to iden...

Design validation focuses on the device itself and involves creating evidence that it meets user needs and intended uses. Process validation, as the name implies, focuses on the production of the devi...

Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. A high-level overview of these design control requiremen...

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has bee...

Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and docum...

Clinical trials for medical devices have many similarities to drug trials, there are some necessarydifferences in the way the trials are designed and carried out. And in some cases, for medical device...

The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. The elements of design controls a...