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

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 issues: Evaluation Tests for Consideration, was expanded (including eg. carsinogenicity and chronic toxicity, reproductive/developmental toxicity) Expansion of … Continued

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

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 complications and even death. Oncolytic viruses exhibit different anti-cancer mechanisms compared with conventional therapies, allowing the possibility for improved effect in cancer therapy. Chemotherapeutics … Continued

Lead Auditor Services ISO 9001:2015 – now available

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. More information about QA-services. 

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

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, Arto Urtti, Jouni Partanen, Jukka Seppälä, Mari Madetoja, Timo Laaksonen, Antti Mäkitie, Marjo Yliperttula Research Article | published 22 Aug 2017 PLOS ONE https://doi.org/10.1371/journal.pone.0183487 ABSTRACT Hydrogel nanomaterials, especially those … Continued

Successful Biocompatibility Project Completed

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 (Biocompatibility Report). The documentation was accepted without any supplementary questions by one of the best notify body in EU region. Client … Continued