Ensuring the biosafety of your medical implants is necessary for getting them in compliance with relevant regulations. Medical implants come into intimate contact with the human body for periods lasting from a few hours to permanently. As such, they are subject to...
Are you a manufacturer? Do you know what particles your workers are exposed to in your working environment? Whether it’s additive manufacturing, assembly, welding or any other process that produces dust or fumes, your workers are being exposed to particles....
Do you manufacture reusable medical devices? If so, your products are likely used in medical facilities around the world. In the EU, manufacturers wanting to sell reusable medical devices must ensure that their cleaning, disinfection, and sterilisation procedures are...
Medical devices are often vital for a patient’s well-being and must therefore be safe and should definitely not worsen their condition. However, there is a high risk of particulate contamination for intravenous and infusion medical devices that can cause health issues...
Are you ready for the upcoming requirements for submission and approval of your food enzymes? In March 2020, EFSA announced changes in how food enzymes compiled in joint dossiers will be evaluated. The deadline for meeting the new requirements is 21 April 2022. If you...
A recent report by the ECHA found that over half the products sold online in the EU were non-compliant with one or more EU requirements with regard to chemicals. These findings resulted in more than 5000 enforcement actions by national authorities. As a product...
