Health, Safety and Environment

2 min

Impact on medical device manufacturers under the MDR 2017/745/EU

The Medical Devices Regulation (MDR 2017/745/EU) is a significant step forward in aligning European Union legislation with technological advancements, advancements in medical science, and the evolution of legal frameworks. By understanding the MDR requirements, manufacturers can navigate the intricate landscape of compliance and contribute to safer and more effective medical devices in the European market.

4 min

The Importance of Understanding Pests in a Food Manufacturing Setting: Protect Your Facility with Pest Awareness Training

If you're a food industry professional concerned about compliance, consumer safety, and maintaining your company's reputation, investing in a Pest Awareness Training Course is more than a smart choice—it's a necessity.

2 min

A comprehensive overview of pre-clinical and clinical evaluation processes

In the dynamic realm of medical device development, the journey from conceptualization to market availability is intricate and demands meticulous evaluation at various stages. This text explains the processes of pre-clinical and clinical evaluations, essential components in ensuring the safety, performance, and regulatory compliance of medical devices.

2 min

AI Medical Device Software

Recently, the European Parliament adopted the Artificial Intelligence Act: MEPs adopt landmark law. The regulation aims to safeguard fundamental rights, democracy, and environmental sustainability. The new set of rules implies a need for more careful examination of the evidence regarding the continuous safety and performance of AI-driven medical device software.

3 min

Delivering solutions to clients: Controlling bird, vermin and insect infestations

Pests can spread throughout a facility very quickly if not managed effectively. They can cause unsanitary issues, leading to legal action or public health concerns. Taking preventative action against pest damage is pragmatic, diligent and much more cost effective in both time and money – we can help you implement this.

3 min

Safe operation of sulfuric acid storage tanks requires regular inspection

Chemical distributor Acinor AS operates a storage tank terminal for sulfuric acid in Fredrikstad, Norway. According to government requirements, inspection of the tank must be carried out every five years. And that's where Kiwa comes in.

4 min

Driving a circular economy with recycled plastic certification

We continue to see developments in the technology behind waste sorting and recycling, driving our move to a more circular economy. But in order for recycling to be effective, safe and economically viable, we need trust: stakeholders throughout the value chain need to understand where the input plastic waste came from and how it is used to make new products.

3 min

Post-Market Surveillance: Key Considerations for Medical Device Compliance

Post-market surveillance (PMS) has undergone significant transformation under the Medical Device Regulation (MDR) in Europe. It marks a new era in the monitoring and reporting of medical device safety and performance. This set of requirements emphasizes the proactive collection and analysis of medical device-related data after a product is placed on the market, allowing manufacturers to reassess the safety and effectiveness of their medical devices continuously.

Kiwa inspector conducting Safety Culture Ladder certification audit in a factory

3 min

All hands on deck for safety

With the Safety Culture Ladder (SCL) organizations can gradually increase their employees' safety awareness and reduce the number of accidents in the workplace. This is still necessary, even in civil engineering, where Dutch infrastructure specialist Van Vulpen is active. The company has been certified at SCL level 4 for several years. Jaco van der Ree, a safety expert at Van Vulpen, explains more about it.