ISO 10993-1: NEW CORRECTED VERSION – Biological evaluation of medical devices

14 December 2018

The new 5th edition of the biocompatibility standard, ISO 10993-1-2018, was released in August and corrected version in October 2018. The new version, released in August, replaces the 2009 version of the standard. We would like highlight some …

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New publication: Antitumor effect of oncolytic virus and paclitaxel encapsulated in extracellular vesicles for lung cancer treatment

2 September 2018

Standard of care for cancer is commonly a combination of surgery with radiotherapy or chemoradiotherapy. However, in some advanced cancer patients this approach might still remaininefficient and may cause many side effects, including severe …

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Lead Auditor Services ISO 9001:2015 – now available

22 February 2018

Made Consulting is now offering an IRCA certified Lead Auditor services (ISO 9001:2015) Mari Madetoja, CEO of Made Consulting, has successfully completed an IRCA certified Lead Auditor -course.

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Nanofibrillar cellulose-alginate hydrogel coated surgical sutures as cell-carrier systems

28 August 2017

Nanofibrillar cellulose-alginate hydrogel coated surgical sutures as cell-carrier systems: A new biomedical devices have great potential in improving patient treatment and recovery Patrick Laurén, Petter Somersalo, Irina Pitkänen, Yan-Ru Lou, …

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New EU rules on medical devices to enhance patient safety and modernise public health

16 May 2017

“Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. …

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Successful Biocompatibility Project Completed

10 November 2016

Made Consulting has recently completed a project with medical device class III product. Our company was responsible for the whole preclinical safety assessment including all safety testing and preclinical documentation to a notify body (Biocompatibi…

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