Category: Articles

HOW TO CHOOSE THE BEST CMS Content Managment

HOW TO CHOOSE THE BEST CMS

What is a CMS platform? A content management system platform is a software that allows you to create a website and manage content without needing expertise in programming and coding such as HTML, JavaScript, and CSS programming languages. With the increase in demand for a digital online presence for all organizations over the years, here […]

5 STEPS IN CHANGE MANAGEMENT change management

5 STEPS IN CHANGE MANAGEMENT

Change management is the systematic approach to the transition or transformation of an organization’s goals, processes or technologies to ensure effective and successful implementation, monitor pre- and post- change activities, and help people within the organization to adapt to the new standards. Organizational change can be either adaptive or transformational. A common use of change […]

COMPUTER SYSTEM VALIDATION (CSV) validation

COMPUTER SYSTEM VALIDATION (CSV)

Computer system validation (CSV), also known as software validation, is how companies regulate their softwares or systems to ensure that they are performing the way they are supposed to work. The FDA defines software validation as, “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and […]

10 Tips to Help Your Technology Team Make the Most of The New Year tech staffing

10 Tips to Help Your Technology Team Make the Most of The New Year

As the new year begins, many technology teams are looking for ways to get back on track after the holiday season. Whether you’re dealing with remote work, budget constraints, or shifting priorities, it can be hard to know where to begin. Here are 10 tips to help your technology team get back on track and […]

BEST PRACTICES IN DATA COMPLIANCE STRATEGIES data compliance

BEST PRACTICES IN DATA COMPLIANCE STRATEGIES

With inncreasing regulatory mandates, intense pressure on pricing and non-stop technological advancements, data compliance modernization is a must for successful life sciences and healthcare organizations. Data compliance seeks to regulate how organizations store, access, and use customer data as well as how data is deleted. Effectively managing data is crucial in protecting an organization from […]

Why Would A Company Consider Outsourcing Technology Projects? outsourcing

Why Would A Company Consider Outsourcing Technology Projects?

There are several reasons why a company or organization might consider outsourcing its technology projects: 1. Access to specialized expertise: Outsourcing can provide access to a wider pool of specialized expertise and skills, particularly for projects that require specific knowledge or experience. This can be particularly useful for companies that do not have the necessary […]

7 STEPS TO BUILDING QMS QMS

7 STEPS TO BUILDING QMS

Building Quality Management System (QMS) consists of clearly written and routinely regulated guidelines and requirements that form the foundation for all procedures in an organization. A successful QMS outlines the key steps for processes and generates preventative measures in a timely way to ensure that the brand, organization processes and stakeholders’ interests are protected.  A […]

Medical Device Development: A Webinar Series

Medical Device Development: A Webinar Series

View one or all of the 4-part med device development webinar series presented by Don DeLauder and hosted by Maria “Cristina” Muise, MBA, Ph.D., MBA, Ph.D. About the Presenter The webinars are presented by Don DeLauder. Mr. DeLauder is an expert in medical device development with over 25 years of experience in the field. He also has 14 […]

EU MDR Transition Tasks EU MDR

EU MDR Transition Tasks

The tough part for the medical device industry is that this landscape of regulations is constantly changing. The European Union’s Medical Device Regulations (EU MDR) came into effect on 26 May 2021 after a three-year transition period, is no exception. The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the […]