9 results found
EU Medical Device Regulation Comparison to ISO 13485
The European Union’s current Medical Device Directive (MDD) 93/42/EEC runs to 60 pages. From May 26, 2020, new devices without a valid MDD/AIMD certificate will have to meet the requirements in its replacement, the Medical Devices Regulation (MDR), which is 175 pages long. This represents an expansion in both scope and detail, so how does ISO 13485 compare against MDR?
Simple Steps to Creating Safer Construction Sites
Construction sites rely on contracted workforces. On US construction sites, for example, one in every five workers is a contractor and this is set to increase to 50% by the end of the decade. Contractor workforces may have flexibility, but they also bring problems in terms of workplace safety. What are the best ways for a construction company to create a safer working environment?
How Will Cybersecurity Maturity Model Certification (CMMC) Affect U.S. Defense Contractors?
Issues concerning the cybersecurity of U.S. defense industry contractors have been raised. Similarities between components in China’s J-31 aircraft and the U.S. F-35 Joint Strike Fighter, among other incidents, have led many to conclude cyber spying is an increasing problem. In response, the Department of Defense (DoD) is introducing the Cybersecurity Maturity Model Certification (CMMC) to secure its Defense Industrial Base (DIB).
Profitable, Competitive and Fashionable: Sustainability in the Textile Industry
Sustainability is a hot topic in the textile industry. Consumers are willing to pay more for products that come from responsible sources. How can a brand use this opportunity to reduce costs and enhance its reputation?
Remote Auditing: Maintaining Certification During the Covid-19 Pandemic
The measures to check the advance of the Coronavirus have had a profound effect upon global business but, despite a general economic slowdown, it has not stopped. Around the world, facilities still need auditing to ensure they remain compliant with government regulations and industry standards. With lockdowns and social distancing being enforced all over the globe, how can businesses ensure continuity in their auditing?
Understanding the Confusion Around U.S. Cosmetics Regulations
Operating in the U.S. can be confusing for cosmetic manufacturers. While products and ingredients, apart from color additives, are not approved by the Federal Drug Administration (FDA), they are regulated through laws concerning interstate commerce. How do companies ensure they comply with the right regulations?
Answering Consumer Concerns About Food Packaging
An estimated 8.8 million tons of plastic waste ends up in our oceans every year. Programs like “Blue Planet II” have highlighted the problem to a global audience and now consumers are demanding change. What are the options for brands that want to introduce more environmentally friendly packaging options?
Why Should You Commit To Carbon Neutrality?
In 2018, the Intergovernmental Panel for Climate Change (IPCC) proposed a Net Zero Emissions (NZEs) control of a temperature rise of 1.5°C by 2050. This became the new goal of the Paris Agreement, which led to the European Union taking the lead by proposing a roadmap towards NZEs. With carbon neutrality now the aim of authorities and companies all over the world, how can businesses benefit from more efficient energy management as they work toward NZEs?
Cybersecurity: Effective Methods for Combating Data Breaches
Data breaches are an increasingly big problem for businesses. They can cause financial and reputational damage that some companies will find it impossible to recover from. What methods are available to organizations to help them protect their data?