Welcome to the MET news section, be sure to check back here regularly for news on MET and in the Medical Device Testing industry itself.
Jan 8, 2021
The revised deadline for MDR compliance is the, 26th of May 2021. There is still time to squeeze some device validation projects in for completion prior to this. More
Jan 5, 2021
At Medical Engineering Technologies we always strive to deliver impeccable customer service. We have managed this with an increasing workload and through the difficulties of 2020. To ensure that this... More
Dec 2, 2020
In a variety of regulatory regions all medicines should be tested for the presence of nitrosamine (N-Nitrosodimethylamine). More
Nov 17, 2020
Our team will be online to privately discuss your projects and show you around our virtual stand . Make contact with us now or through the venue networking facility. E... More
Nov 2, 2020
USP 1207 Closed Container Integrity Testing can be performed using a Vacuum Pressure Decay method. The method is also suitable for leak testing of impermeable medical device packaging . More
Nov 2, 2020
The review explains the changes that have been made to the standard since the previous version. It was commissioned by BSI for their Compliance Navigator: https://compliancenavigator.bsigroup.com/
More
Oct 27, 2020
A clear explanation of requirements and how to provide evidence of compliance has been published in Ondrug Delivery magazine. More
Oct 19, 2020
ISO 80369: Small-bore connectors for liquids and gases in healthcare applications.
ISO 594: Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment. More
Oct 12, 2020
Changes to ISO 10993 and the implementation of the MDR, coupled with intensive activity in biosimilars development is driving an increased need for ISO 10993-18 and extractables and leachables testing... More
Oct 2, 2020
MET has published two medical device usability case studies. The first is for a glucose monitor and the second for an emergency epinephrine auto-injector. More
Sep 3, 2020
When the pandemic hit British shores in March 2020, businesses up and down the country were forced to change tack, some had to batter down the hatches whilst others had... More
Sep 3, 2020
We are proud to welcome Zhané Rose-Amankwa into our team. She trained as an apprentice at Greenwich University and has experience in biological, chemical and physical laboratories. Zhané is currently... More
Aug 17, 2020
Sarah Philpott our Sales Professional is facing a daunting challenge. A minimum of 10 hours (20 hours for some people) in seawater at a maximum temperature of 16ᵒC whilst swimming... More
Jul 8, 2020
The podcast is one in a series produced by the Leaders Council of Great Britain and Northern Ireland. This is an organisation which has been set up to promote good... More
Jun 22, 2020
The new (2018) version of ISO 10993 moves the emphasis of biocompatibility from biological testing to risk analysis and chemical characterisation with toxicity risk assessment
What does... More
Jun 11, 2020
The current version of this standard is now over a year old. How much has changed in ISO 11607-1:2019
Packaging for terminally sterilized medical devices and how much had... More
May 29, 2020
The options are pharmaceutical container extractables and leachables studies or following ISO 10993 the medical device biocompatibility standard. Medical Engineering Technologies has published a guide to progressing your projects in... More
May 20, 2020
Testez vos dispositifs médicaux en France More
May 11, 2020
This FDA emergency injector guidance published in April 2020, indicates how to select a marketing application route and how to make that application.
Because emergency injectors are used in... More
Apr 6, 2020
At MET we are helping battle Coronavirus with our chemistry team hard at work. Testing ventilation systems, we are busy performing particle and vapour release analyses. More
Mar 20, 2020
The revised version of this standard gives information on the generation of chemical characterisation data for your Biological Evaluation Report. More
Mar 16, 2020
The Washington post has published an article which explains very, very clearly how isolation and social distancing influences the spread of the Corona Virus. (Acceptance of the free subscription is... More
Feb 12, 2020
Medical Engineering Technologies (MET) has published a guide to ISO 10993-1:2018. The article ‘ The mysteries of the 2018/2019 edition of biocompatibility standard ISO 10993’ appears in Medical Plastic News... More
Nov 15, 2019
Increased interest in biologics and biosimilars is one of the factors driving the need for delivery devices at the interface between devices and pharmaceuticals. More
Nov 1, 2019
Medical Engineering Technologies SAS, is headquartered in France and will be providing services from a base in Calais. More
Oct 30, 2019
MET Ltd, société Britanique basée à Douvres, annonce le lancement de sa filiale Medical Engineering Technologies SAS, ouvrant ses portes en France dans la Côte d’Opale More
Oct 28, 2019
ISO 21726:2019 Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents - is a new standard to aid... More
Oct 1, 2019
Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. The changes are mostly subtle; the biggest is (maybe) the addition... More
Aug 2, 2019
Testing is provided to ISO 20072 Aerosol drug delivery device design verification. Requirements and test methods. More
Jun 20, 2019
Traditionally, the main area of concern regarding interactions between a formulation and a device has been limited to the container storage system for the formulation. There is mounting interest in... More
Jun 10, 2019
The European Medicines Agency has published draft quality requirements EMA/CHMP/QWP/BWP/259165/2019 for delivery devices and other integral and non-integral DDCs.
Non integral DDCs include such things as refillable injector pens,... More
Feb 28, 2019
Published in January, ISO 11040-6:2019 Prefilled Syringes - Part 6: Plastic barrels for injectables and sterilized sub assembled syringes ready for filling, has several changes from previous versions. More
Feb 7, 2019
If a medical device has short term surface contact, it clearly does not require the same amount of vigour in the investigation of the availability of chemicals (to the end... More
Feb 1, 2019
The standard, ISO 19761 Additional Lubricants for natural rubber condoms – effects on strength, has some significant variations from ASTM D 7661. More
Jan 16, 2019
Here, we explain the difference between Safety Concern Threshold (SCT) and Analytical Evaluation Threshold (AET).
More
Dec 6, 2018
Does my medicinal product need to comply with MDR Article 117?
More
Dec 6, 2018
When will my containers need to comply with USP <661.1> and USP <661.2>?
More
Nov 1, 2018
ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods is a standard which provides validation tests for a very specific size of needle. There are many... More
Oct 31, 2018
ISO 19227 Implants for Surgery--Cleanliness of Orthopaedic Implants--General Requirements – was published early in 2018. It is a new standard issued with the intention of reducing diversity in the application... More
Oct 16, 2018
ISO 11607-2 Packaging for terminally sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes, has been revised and will be republished in November 2018. Part... More
Oct 15, 2018
There are a variety of international standards pertaining to medical needles. For pen injectors and insulin needles the most relevant is IS0 11608-2 . There are a variety of other... More
Sep 4, 2018
IS0 10993-1 updated to include emphasis on chemical assessment
More
Aug 30, 2018
IS0 11608 is the most important standard for dose accuracy testing when it comes to injection devices. More
Aug 28, 2018
MET is expanding ISO 11040 and IS0 11608 laboratory testing capacity, to help address your pre-filled syringe regulatory requirements. More
Aug 21, 2018
MET is providing full testing to ISO 20696, which replaces EN 1616 for Foley catheters. More
Mar 17, 2017
Assessment of ambulatory injection devices by MET
Innovation continues to drive the development of new wearable injector devices with the need for adapting to different dosing regimens and fluid... More
Sep 19, 2016
The testing of contraceptive devices and gynaecological rings by MET More
Sep 16, 2016
For these kinds of validations, the pens and syringes are mounted in a transparent chamber. The inside of the chamber is then subjected to simulated air transit whilst the air... More
Jun 23, 2014
The Bubble Emission Test is a method of determining the integrity of medical packaging. Bubble testing involves the application of pressure to the underside of a submerged material. More
Apr 1, 2014
For medical device package validation, shelf life testing and transit simulation are often treated as entirely separate issues. But can we really be so quick to separate the two? More
Oct 25, 2013
This article first appeared in Medical Packaging Innovation
The shelf life of terminally sterilised medical devices should be validated using both accelerated and ‘real time’ ageing, according to ISO 11607.... More