Extractables and leachables: What the E&L are they?!
Blog articles
When we are unfortunate enough to have to take a drug or to be in contact with some sort of medical device, we are going to be exposed to more than maybe we bargained for...click to read about how we can help.
Medical device submissions – protecting supplier confidentiality
Blog articles
We recently described – using a fruit label as an example – how an independent consultancy such as bibra could act as a third-party broker, providing a manufacturer with a safety evaluation of a multicomponent product while also protecting suppliers’ confidentiality over chemical composition. Here, we describe another example, in this case relating to a medical device submission to a Regulator or Notified Body.
Pet food safety: How much do you know about what you feed your pets?
Blog articles
As they open the tin, harassed by their “best friend” or feline lodger, many pet owners must have at some time wondered about the quality of the product that they are adding to the food bowl. Click to read more about our work in pet food safety.
The dawn of a new age in medical device risk assessments
Blog articles
After a development process that stretches back to the beginning of 2018, ISO has published the updated version of the International Standard ISO 10993-17. It has been a mammoth effort, involving over 100 scientists from 20 different countries (including bibra Senior Toxicologist, Chris Waine), and one that the toxicological and medical device worlds have been waiting for with bated breath.
CAATs out the bag: Unexpected Animal Use Figures Under REACH Testing
Blog articles
The European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, which came into force in 2008, emphasised that “before (proposing) additional animal testing, use of all other options should be considered. It is important to emphasise that testing on vertebrate animals must only be conducted or proposed as a last resort”.
The safety of multi-component products
Blog articles
Who can honestly say that they haven’t, now and then, bitten into a tasty apple or pear only to discover they’ve accidentally munched on a fruit label. You and I will probably (if not distracted) remove and discard said offending item. But young children and compromised adults might ingest a label on occasion. Click to read more about this dilemma.
In Silico Testing for Toxicology Assessment
Blog articles
Toxicity assessment is a key part of the drug discovery and development process. Many of the tests that use laboratory animals to investigate drug safety are time-consuming, expensive and complicated by ethical concerns. Investigative toxicology strategies have therefore adopted a tiered approach employing in silico and in vitro methods in order to ideally eliminate, or at least reduce, in vivo experimentation. Here, we attempt to give a simplified overview of the complex and multifaceted topic that is in silico toxicology assessment. Strap in and hold on tight…
Medical devices and CE certification
Blog articles
A medical device placed on the EU market must have a CE (“Conformité Européenne”) certification and comply with the EU Medical Devices Regulation (MDR; Regulation (EU) 2017/745) [1] or the EU In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation (EU) 2017/746) [2]. Read our overview on the process, plus find out how we can help.
Safe Cosmetic Testing Methods without Animals
Blog articles
Shampoo, perfume, lipstick, toothpaste – we all use at least some cosmetics in our everyday lives, and assume the manufacturers and regulatory agencies have our best health interests at heart. Here, we provide an overview on the use of laboratory animals in cosmetic safety testing, and discuss alternative non-animal-based test methods.
Aspartame: Hazard vs Risk (and why it’s got everyone in a tiff)
Blog articles
Earlier this month, The International Agency for Research on Cancer (IARC) classified the popular non-sugar sweetener aspartame as “possibly” carcinogenic to humans which has, understandably, raised concerns within industry and left a taste in consumers’ mouths that was far less sweet than they were used to.