Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Struggling to demonstrate the safety, performance and benefits of your medical device software under the MDR?
On demand
1h
Medical Devices
English
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
Description
Join our webinar to explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices.
We’ll discuss the critical role of clinical validation starting from the design phase and guide you on how to compile the necessary evidence to meet MDR requirements.
You’ll learn how to ensure your software not only achieves market access but also upholds patient safety and delivers effective healthcare outcomes.
What you'll learn
- Gather and compile robust clinical data to support your conformity assessment.
- How the classification of your MDSW impacts clinical validation requirements.
- Best practices for integrating clinical validation considerations into your design process.
- The importance of clinical evaluation for technical documentation and market access.
Speaker
Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.
Don’t miss the opportunity to learn and engage with professionals in the field.
Pia Gyselen
Lead Medical Writer
Pia is an experienced expert with 26 years in the medical industry. She holds a Master’s degree in Medical Biochemistry from the University of Antwerp,
Currently, Pia leads the Medical Writing team at QbD Clinical, overseeing the creation of regulatory documents for medical devices, in-vitro diagnostics, and clinical research. She collaborates with cross-functional teams to ensure compliance and accuracy in regulatory submissions.
Previously, Pia was the Lead of Clinical Operations at Fluidda, where she shaped the department and managed the team. She also held senior roles at Janssen Research & Development, where she managed large-scale global clinical trials, focusing on strategic planning, risk management, and operational execution.
Pia is a lifelong learner who thrives on tackling multiple projects and enjoys brainstorming innovative solutions, mentoring others, and turning ideas into action.
Watch here
Submit your contact details to access the full webinar anytime. Don’t miss out on valuable insights and actionable strategies from our industry experts.
First name*
Last name*
Professional Email*
Company name*
Role*
Please SelectC-level / VPDirector(Sr.) ManagerSpecialist/AnalystIntern/ApprenticeIndividual contributorOther
Department*
Please SelectStrategy & ManagementRegulatory & VigilanceQuality Assurance & ControlIT & Digital InnovationManufacturing & ProductionProduct DevelopmentResearch & InnovationClinical Affairs & OperationsMedical AffairsMarket AccessSales & MarketingHRProcurementOther
Country*
Please SelectAfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAsia/Pacific RegionAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCaribbean NetherlandsCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCook IslandsCosta RicaCote d'IvoireCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the CongoDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaEuropeFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern and Antarctic LandsGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmar (Burma)NamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestinePanamaPapua New GuineaParaguayPeruPhilippinesPitcairn IslandsPolandPortugalPuerto RicoQatarRéunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluU.S. Virgin IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVatican CityVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabwe
Industry*
Please SelectMedical DevicesIn Vitro DiagnosticsPharmaBiotechAnimal HealthService providerConsumer HealthOther
Would you like a one-on-one with our team?
Content Title
Content Type
Content Division
Content Industry
QbD Group is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.
-
Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the QbD Group.
-
I consent to the privacy policy and understand that my personal data will be stored and processed *
Upcoming webinars
.jpg)
From R&D to market IP and regulatory strategy across the product life cycle
Join this Biovia x Gevers x QbD Group webinar to explore product life cycle strategies, focusing on R&D, regulatory alignment, and Quality by Design insights for life sciences professionals.
Medical Devices
Read more
.jpg)
Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations
Manage the risk of nitrosamines in the pharmaceutical industry. Join our webinar and learn about regulation and risk analysis from experts.
Pharma & Biotech
Read more
From Strategy to First-in-Human: A Practical Roadmap for Biotech Development
Join our webinar to learn how to navigate nitrosamine risks and streamline your biotech development from early planning to first-in-human trials. Register now for expert insights.
Pharma & Biotech
Read more
-1.jpg)
AI in Life Sciences
Join our webinar with delaware on implementing compliant AI in life sciences. Learn best practices and avoid pitfalls in GxP environments from industry experts. Register now.
Software Solutions & Services
Read more
Discover all
We share the latest news
Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
