All Features
Ayush Soni
Audits and inspections are critical components of industrial safety management. These processes help organizations ensure compliance with legal requirements, identify risks, and improve workplace safety and operational efficiencies. Conducting regular audits and inspections is not just a regulatory…
Jonathan R. Todd
Geopolitical risk is emerging as one of the greatest challenges facing domestic and international business today. It has risen from a boardroom issue to one drawing the awareness and attention of both personnel and the general public. These days everyone knows the word “supply chain” and has some…
Maria DiBari
This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…
Etienne Nichols
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Nick Haase
After spending years working alongside frontline manufacturing teams, I’ve come to see one thing clearly: Preventing incidents isn’t just a legal requirement. It’s the heartbeat of a healthy operation. With workplace safety making headlines daily—often with tragic details—it’s time to highlight how…
Saurabh Joshi Shripad
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…
Sergey Sukhovey
The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection nationwide…
Megan King
When first responders need to rescue people from an earthquake-ravaged home, they need real-time information. If law enforcement officers are looking for a shooter in a crowded building, they must learn everything they can about the scene.
Emergency responders need to know where people are and…
Eric Linxwiler
Quality management has evolved far beyond traditional checklists and periodic inspections. For complex supply chains, quality is no longer a static endpoint. It’s a dynamic real-time process deeply interwoven with collaboration, transparency, and data-driven decision-making. As supply chains grow…
Saili Sonawane
In a growing business milieu, ISO quality management system compliance ensures that organizations meet global standards for quality, safety, and efficiency. However, maintaining compliance with ISO frameworks such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO…
John Tschohl
What are the elements of a successful team? In a nutshell—whether it’s an athletic team, a dance team, or a business team—the critical elements are people who are knowledgeable, dedicated, productive, work well with others, and constantly seek to improve their skills.
But hiring and firing are…
Harish Jose
Today I’m looking at the free energy principle (FEP) by the British neuroscientist Karl Friston. The FEP basically states that to resist the natural tendency to disorder, adaptive agents must minimize surprise. This has implications for the gemba, as you’ll see.
A good example to explain this is…
Angie Basiouny
Wharton management professor Peter Cappelli is routinely asked to predict the future of work. His expert answer is always the same: “The future looks like the past.”
He’s not trying to be cryptic. It’s just that the big changes ushered in by the pandemic five years ago are still unfolding—remote…
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Malcolm Chisholm
Data are the fuel of the Information Age, and all organizations acknowledge the value of well-managed corporate data assets. The problems start when we begin to ask just exactly how the data assets are to be well managed.
In response, many organizations have put data governance departments in…
Angie Basiouny
Hospital patients rate their pain on a scale of 1–10. Teachers grade on a curve. Sports fans spend hours debating stats on their favorite teams. Even the most ardent language lover can’t deny the power of numbers to convey information, especially when choices need to be made.
A new study from…
Prashant Kondle
Unplanned equipment downtime costs manufacturers an estimated $50 billion annually, according to a study by Deloitte. It is estimated that unplanned downtime costs more than $100,000 per hour. Traditional maintenance approaches—whether reactive or scheduled—are not sufficient to address these…
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Horacio Falcão
Wouldn’t it be wonderful if we could outsource to technology the complex, laborious, and often emotionally intense process of negotiating? Until recently, the idea of merging negotiation and AI was only a dream. However, the launch of more sophisticated AI systems has changed how we approach the…
Megan Wallin-Kerth
It’s 2024, and the age of automation has largely taken over our phones, computers, and businesses. This isn’t entirely a bad thing, you understand. It gives us the ability to spend time and money elsewhere—from investing in staff to spending more time on innovating technology rather than whittling…
Erin Vogen
For many maintenance teams, the story is all too familiar: Limited resources make it difficult to anticipate equipment failures, which leads to frequent, costly breakdowns. During these moments of crisis, miscommunication and disorganization only amplify the problem. This perpetuates the perception…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Jennifer King
A study by Upwork has revealed that about 22% of the American workforce will be working from home by 2025. Remote work is here to stay, bringing many benefits along with it—including significant cost savings for businesses and the promise of a better work-life balance for employees. However, the…
Marian Merritt
Cybersecurity is a fast-growing field with a constant need for skilled professionals. But unlike other professions—like medicine or aviation—there’s no clear-cut pathway to qualifying for cybersecurity positions. For employers and job seekers alike, this can make the journey to building a team (or…
