Freudenberg Medical的动态

?? When looking to identify prospective resources to help navigate the industry’s complex regulatory and reimbursement pathways, device companies are accustomed to reaching out to the medtech trade associations?AdvaMed?and?Medical Device Manufacturers Association (MDMA). ?? A less well-known, but potentially equally valuable asset is the?Medical Device Innovation Consortium (MDIC). A panel at last November’s?MedTech Strategist?San Francisco Innovation Summit featured the leadership of MDIC highlighting the broad nature of the organization’s resources and explaining how large and small product companies can benefit from these efforts. ?? This interview with the leaders of the?Medical Device Innovation Consortium (MDIC)—Andrew Fish,?Chip Hance, and?Andrew Cleeland—highlights the broad bandwidth of the organization’s partnership with industry and regulators, and the opportunities these relationships provide for companies of all sizes:?https://bit.ly/3w5BHJX #MDIC?#reimbursement?#regulatoryaffairs?#medicaldevices?#medtech?#medtechindustry?#medtechinnovation

We've been producing some much larger fluidic parts at Rapid Fluidics recently with a series of 320x280mm manifolds. Even at a 50 hour print time, they're still weeks faster than milling and bonding. But I figured this would be a better example to show off. Worth watching through, we got a bit experimental. Does it still count as #microfluidics at this scale? Who'd like me to bring it to MEDICA - Leading International Trade Fair this week? #additivemanufacturing #rapidprototyping #bioart #labautomation #fluidhandling #rapidfluidics #medica2024 #compamed2024

Regulatory Do’s and Don’ts: Tips from FDA The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. The target audience is entrepreneurs new to the FDA regulatory world that could benefit from support in better understanding when to contact the Agency during preclinical development. #regulatoryaffairs #FDA #biotech #pharmaceutical #productdevelopment #startup #lifesciences #clinical #clinicaldevelopment #preclinical #medicalwriting #CMC #eCTD #EMA #TGA

Brisa Advisors at FIME 2024: Connecting Innovations to the Brazilian Medical Device Market We are excited to announce that Brisa Advisors will be present at FIME 2024, the largest medical device trade show in the Americas, taking place from June 19 to 21 in Miami, USA. This event is a unique opportunity to explore the latest innovations in medical technology and discuss the newest trends in the departament. FIME brings together healthcare professionals, manufacturers, distributors, and regulators from around the world, providing a conducive environment for networking and knowledge exchange. As experts in market access and regulatory compliance with ANVISA, Brisa Advisors is committed to helping companies navigate the Brazilian market safely as your Sales Partner, ensuring the competitive effectiveness of your products. If you wish to market your products in Brazil through a strong, competitive, and highly reliable structure, schedule a conversation with our CEO, Marcelo Brisolla, and explore the best strategies Brisa Advisors can offer to expand your business in the region. During FIME, our team will be available to discuss how we can support your company in entering this market, from selecting the best sales channels, obtaining regulatory approvals, to effective commercialization. Schedule a meeting ( https://lnkd.in/dmePASFP )?at the trade show and discover how we can collaborate to accelerate the entry of your medical devices into the Brazilian market. We look forward to seeing you at FIME 2024! Click?to learn more about FIME on our blog. https://lnkd.in/dpnquqJV #FIME #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices

Investor Update with ShareCafe and Finance News Network: Our APAS automated culture plate reader is ?????????????? ?? ?????? ???????????????? ???? ?????????????????????????????????? ?????????????????????? for pharmaceutical manufacturing. Improved commercial outlook worth listening to (https://lnkd.in/gGjgQnFx)

Essential for early-stage life sciences companies! ?? Join this insightful webinar on September 4th to explore FDA resources that can guide your oncology innovations through the regulatory process.? ? Secure your spot today ?? https://lnkd.in/ehUeuvsz? ? #LifeSciences #Oncology #FDAWebinar

Let's go ?? Miriam Schulze and Deniz Kaytan are ready to meet you at PharmaForum 2024 in Saarbrücken. Get to know them, our platform MedicalOne Connect and YOOme as your partner for the entire medical device journey. #medtech #digitizepharma #yoome #pharmaforum2024

?? Save The Date!?? ? Lebon Aymeric , Medtech Commercial Director at PLG will host 2 speaking sessions at MEDICA - Leading International Trade Fair: ·???????(Slot 1) ?? 12 November | 15:15 – 15:45 ?? German Pavilion Stage Topic: Developing an Effective Regulatory Strategy: Securing a Seamless IVDR Transition Aligned with Your Business Objectives (for non-IVD, jRUO, IVD products) ·??????(Slot 2)??? 13 November | 15:30 – 16:30 ?? German Pavilion Stage Topic: Clinical Validation for Software Integrating AI Do not miss your chance to connect and be part of these sessions where we will cover essential and emerging challenges in the Medtech industry, offering valuable insights into both regulatory strategy and clinical validation for AI-driven software. From 11 – 14 November, meet ProductLife Group at the German Pavilion, C80, Hall 3. ?? Connect now on MEDICA match-making app to secure meetings with our team: Pascale Cousin, Lebon Aymeric, Keval Bhoola, Vincent L. and Fernando Mayoral Alonso. #ProductLifeGroup #MEDICA #Dusseldorf #MedicalDevices #IVDR #ClinicalValidation #RegulatoryStrategy #AIinHealthcare #MedicalSoftware #GlobalHealthcare #LifeSciences #GermanPavilion #MedTech #HealthcareInnovation

Today marks the first day of the medical Industry Scientific Exchange (ISE) for new sterilization modalities, hosted in Munich by TüV SüD . This event brings together over 75 participants from over 30 medical device manufacturers, sterilization providers, FDA and TüV SüD. These experts will have a scientific exchange of ideas on how to address challenges to packaging, biocompatibility, and material science for new sterilization modalities. The presentations and exchange so far has been very enlightening. Looking forward to what the next 3 days bring as experts exchange ideas on bringing these new sterilization technologies forward. #tuvsud #FDA #medicaldevices #sterilization

Thanks Chamber of Engineers for giving me the opportunity to bring out some key aspects for engineers in Pharma/Biotechs: 1) its about reducing the risk... we have to be able to explain this to non technical regulators in simple and clear terms that they can understand & defend! 2) accept to be challenged... there is always some form of improvement 3) be humble... the best ideas are normally coming from non-engineers! 4) think beyond... what we design, validate, implement will most likely not be utilised by engineers or even any form technically competent person #operationalexcellence #pharmaceutical #biotechnology