{"id":89267,"date":"2023-09-05T08:40:55","date_gmt":"2023-09-05T06:40:55","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?p=89267"},"modified":"2025-01-16T13:24:25","modified_gmt":"2025-01-16T12:24:25","slug":"meet-our-speakers-at-the-biological-and-clinical-evaluations-conference-for-medical-devices","status":"publish","type":"post","link":"https:\/\/lightweb.dev\/s\/key2compliance\/news\/meet-our-speakers-at-the-biological-and-clinical-evaluations-conference-for-medical-devices\/","title":{"rendered":"Meet our speakers at the Biological and Clinical Evaluations Conference for Medical Devices"},"content":{"rendered":"

We are excited and proud to have some of the most experienced speakers within the industry present at our Biological and Clinical Evaluations conference in Copenhagen on the 4-5th<\/sup> of October<\/strong>.<\/h3>\n

Meet our speakers:<\/h3>\n

Lisa Moloney<\/strong>, <\/strong>Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental , BSI Notified Body
\n<\/strong>Biological evaluation over the life cycle of a medical device \u2013 Aspects to be considered<\/p>\n

Danielle Giroud<\/strong>, <\/strong>Founder, CEO, MD Clinicals SA
\n<\/strong>Clinical evaluations and investigations \u2013 how to align from a risk perspective<\/p>\n

Crystal D\u2019Silva<\/strong>, <\/strong>Senior Manager, Pre-Clinical Toxicology, Baxter International Inc<\/strong>
\nProposed revisions to ISO 10993-1: Renewed guidance recommendations illustrated through a case study using true risk assessment approach for the biological safety evaluation of a hemodialyzer.<\/p>\n

Gianluca Colucci<\/strong>, <\/strong>In-house Clinician, Intertek
\n<\/strong>Is it good enough? An interactive conversation among stakeholders in the certification process<\/p>\n

Jan Peeters<\/strong>, <\/strong>Founder & Senior Consulting Specialist<\/strong>, <\/strong>Peeters MD Consulting
\n<\/strong>Planning comprehensive toxicological evaluations by linking ISO 10993 part 17 with part 18<\/p>\n

Stefan Roth<\/strong>, <\/strong>Professor of product development\/construction Applied plastics technology, Hochschule Schmalkalden University of Applied Science
\n<\/strong>Medical Grade Plastics \u2013 Requirements and Regulations on Plastics for Medical Applications<\/p>\n

Ulrika Andersson<\/strong>, <\/strong>Chief Compliance Officer, Colzyx
\n<\/strong>Is a regulatory high-risk device a high risk for the patient?<\/p>\n

Stefan Jernberg<\/strong>, <\/strong>Chief Regulatory Officer, Cuviva
\n<\/strong>The path to MDR Class IIa Certification of a Medical Device Software<\/p>\n

Sofia Segersson<\/strong>, <\/strong>Entrepreneur, influencer, founder, Diabetesia.se
\nHow life improves when the gadgets improve<\/strong><\/p>\n

Peter L\u00f6wenhielm, Innovation advisor Life Science, KI Innovations
\nLost in translation: Navigating the regulatory landscape from bench to bedside<\/strong><\/p>\n

Ina Sch\u00e4ffner, <\/strong>Medical Science Liaison, Abilia
\n<\/strong>Getting your product to the market \u2013 how clinical evaluation can support Reimbursment and Health Technology Assessment (HTA)<\/p>\n

Louise Hansen<\/strong>, <\/strong>Pharma and MedTech coordinator, Region Nordjylland, Denmark
\n<\/strong>How hospitals and companies collaborate in Denmark on clinical investigations<\/p>\n

Maria Lyse<\/strong>, <\/strong>Clinical Research Specialist, Ambu A\/S
\n<\/strong>The literature route to clinical data \u2013 a case of equivalence<\/p>\n

Maria Lindgren<\/strong>, <\/strong>Director, Clinical development, Key2Compliance
\n<\/strong>Is it good enough? An interactive conversation among stakeholders in the certification process<\/p>\n

We hope to meet you in Copenhagen on the 4-5th<\/sup> of October<\/strong>!<\/p>\n","protected":false},"excerpt":{"rendered":"

We are excited and proud to have some of the most experienced speakers within the industry present at our Biological and Clinical Evaluations conference in Copenhagen on the 4-5th of October. Meet our speakers: Lisa Moloney, Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental , BSI Notified Body Biological evaluation over the life cycle […]<\/p>\n","protected":false},"author":18,"featured_media":89274,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":1,"footnotes":""},"categories":[21],"tags":[292,235,244,186],"blog-subject":[],"class_list":["post-89267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-biological-safety","tag-clinical-development","tag-clinical-evaluation","tag-medical-devices"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/89267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/18"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=89267"}],"version-history":[{"count":0,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/89267\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/89274"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=89267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/categories?post=89267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/tags?post=89267"},{"taxonomy":"blog-subject","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/blog-subject?post=89267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}