HEMEX’s Post

Exciting News! OMC Medical is thrilled to announce our participation in the Asia Labex Exhibition! 🌟   📅 Event: Asia Labex Exhibition   📍 Location: [Asia Labex](https://asialabex.com/)   Join us at this premier event to explore innovative solutions, discuss business opportunities, and learn how we can help you navigate the complexities of medical device regulations.   🔗 Connect with OMC Medical: We invite you to visit our booth to discuss your regulatory needs and discover how our expertise can benefit your business.   📞 Set Up a Meeting: Want to ensure dedicated time with our experts? Schedule a meeting with us in advance. Email us at [email protected] to book your appointment.   Our Services:   Regulatory Strategy and Consultation: Tailored guidance to help you understand and meet global regulatory requirements. Technical Documentation: Comprehensive support in creating and maintaining detailed technical files. Clinical Evaluation Reports (CER): Expertly crafted CERs to demonstrate the safety and performance of your medical devices. Post-Market Surveillance (PMS): Robust PMS plans and reports to ensure continuous compliance. Quality Management Systems (QMS): Implementation and maintenance of QMS to ISO 13485 standards. Regulatory Submissions: Assistance with preparation and submission of regulatory documents to authorities worldwide. Global Product Registrations: Comprehensive services to achieve product registrations in global markets. Authorised Representative Services: Acting as your EU Authorised Representative, Swiss CH- REP, India, Korea, China and all other countries around the world to facilitate compliance with local country regulations. Training and Support: Customized training programs to keep your team updated on the latest regulatory changes. Don't miss this opportunity to engage with industry leaders and stay ahead in the medical device market. We look forward to connecting with you at Asia Labex! #AsiaLabex #OMCMedical #MedicalDevices #RegulatoryCompliance #BusinessOpportunities #Exhibition #MeetUs #MedicalInnovation #RegulatoryExperts #Healthcare #MedicalDeviceRegulation #GlobalProductRegistration #AuthorizedRepresentative #QualityManagement #TechnicalDocumentation #ClinicalEvaluation #PostMarketSurveillance  

We are ready for MEDICA - Leading International Trade Fair 2024! CMC Medical Devices team is already in Düsseldorf, prepared to kick off this exciting edition of one of the world's most important healthcare fairs. Come visit us and discover how we can support you with regulatory challenges and explore the latest innovations in the sector together. You'll find us in Hall 6 - G62. We’re here to assist you and provide the support you need! #MedicalDevices #MedTech #HealthcareInnovation #DigitalHealth #PatientSafety #MedicalTechnology #HealthcareSolutions #RegulatoryAffairs #ClinicalTrials #HealthcareIndustry #MedicalDeviceManufacturing #MedDeviceRegulations #MedicalDeviceDesign #HealthcareStandards #GlobalHealth #ConnectedHealth #SmartHealthcare #HealthTech #WearableTechnology

A team of experts from Emergo by UL will attend Hospitalar. Details below. Many interesting recent regulatory developments in Brazil which Emergo by UL has previously shared, in the event you missed it, this is delineated again below: *Normative Instruction IN 290/2024 on the Equivalent Foreign Regulatory Authority (AREE) and leveraging authorizations from four of the former GHTF founding members with the regulator, ANVISA: https://lnkd.in/gz-KfUth. *Resolution RDC 850/2024 to expand B-GMP certificates supported by MDSAP certificates to four years: https://lnkd.in/gHyheiMV . *Three guidances to further enhance the Resolution RDC 830/2023: https://lnkd.in/gDz_FY3S   and https://lnkd.in/g42YBwUP . *Resolution RDC 848/2024 on Essential Safety and Performance Requirements, note now applies to IVDs as well: https://lnkd.in/grzWqUir . In a few weeks, one of our SMEs (Lilian Pinheiro) hosts an upcoming webinar (30 April) on RDC 830/2023 (on IVDs): https://lnkd.in/gNeQ_gqa. Note questions can be submitted in advance to [email protected] . Global regulatory harmonization is clearly a theme! Go "reliance"! #medicaldevice #regulatory #regulatoryaffairs #ivd #anvisa #webinar #medtech #regulatorycompliance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Upcoming Pharmacy Events in Ireland You Can’t Miss Looking to expand your knowledge and network with fellow professionals? There are several pharmacy-related events coming up in Ireland this year, including workshops, conferences, and seminars. These events provide opportunities for continuing education, networking, and staying informed on the latest industry trends. Check out these events happening soon and make sure you’re part of the conversation. Check out these events happening soon and make sure you’re part of the conversation. #PharmacyEvents #IrelandPharmacy #NetworkingOpportunities #PharmacyProfessionals

Meet our Regulatory Affairs specialists at MEDICA - Leading International Trade Fair! #Medica is one of the world's largest B2B events in the #HealthcareSector. The fair brings together more than 5,000 exhibitors from around 70 countries and attracts more than 80,000 global visitors, showcasing the latest innovations in #medicaldevices, diagnostics and healthcare technology. Our #consultants specializing in Regulatory Affairs in #Brazil, will be around the event following trends in the sector and will be available for conversations about regulation in the Brazilian market. If you will also be at the event, come and talk to us about Medical Devices, #IVD, #Cosmetics and #Hosting (Legal Representative in Brazil for companies that want to operate in the Brazilian market without having to open a local subsidiary). We are ready to connect, innovate and share knowledge about the regulatory area of medical devices in Brazil. 🚀 OUR TEAM Rose Prado Cristiane Ap. de O. Aguirre Roberta Kleiner Nicoli Bressan Motooka 🌐 Visit our website: https://lnkd.in/dMQ3sDVm #VeraRosas #VeraRosasGroup #BrazilianRegulatoryAffairs #BrazilianRegulatoryConsultancy #LegalRepresentative #BrazilianPartner #RegulatoryConsutancy

Discover Taiwan’s Cutting-Edge Medical Solutions at MEDICA 2024 Düsseldorf, Germany – MEDICA, the world’s largest medical trade fair, will take place from November 11 to 14, 2024. This year, 84 Taiwanese companies will participate across three halls (3, 6, and 16), proudly led by the Taiwan External Trade Development Council (TAITRA). These companies will highlight Taiwan's exceptional capabilities in quality and technology, seeking to forge valuable partnerships with global stakeholders. Taiwan is globally recognized for its robust supply chains in ICT and precision machinery, establishing itself as a key partner in providing medical products through OEM and ODM services. This dynamic ecosystem not only showcases Taiwan's innovative spirit but also reinforces its crucial role in the global supply chain, delivering smart and high-tech medical products and solutions. For details on all Taiwanese companies and their products, please visit the Taiwan Pavilion website at https://lnkd.in/gQFhqZ42

Welcome to Week 42 of 52 Weeks of WOW: Word of the Week Wednesdays Word of the Week: INDUSTRY SPONSOR Industry Sponsor: A company or organization within the healthcare sector that provides financial support for a medical event, contributing to its success and sustainability. Why is this important? Industry sponsors play a crucial role in supporting medical events by providing funding, resources, and expertise, enabling organizers to deliver valuable educational and networking opportunities to attendees. What does the planner need to do? Cultivate relationships with potential industry sponsors, tailor sponsorship packages to align with sponsors' objectives and interests, and maintain clear communication and accountability throughout the sponsorship process. How can planners apply it? By collaborating with industry sponsors, planners can secure vital financial support, access industry insights and innovations, and enhance the overall quality and impact of the medical event for attendees. Key takeaway: Industry sponsors are indispensable partners in the success of medical events, contributing financial resources and industry expertise to enrich the conference experience and advance healthcare education and innovation. #52WeeksofWOW #MEDiC #MEDiCseries #pharma #biotech #medicalmeetings #mmp #eventsindustry #meetingsandevents #eventprofs #medcomms #medicalcommunications #sponsor

𝗘𝘅𝗽𝗹𝗼𝗿𝗲 𝗖𝘂𝘁𝘁𝗶𝗻𝗴-𝗘𝗱𝗴𝗲 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗮𝘁 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗶𝗻 𝗦𝘁𝗼𝗰𝗸𝗵𝗼𝗹𝗺 Don't miss the upcoming GBA Key2Compliance conference on the product life cycle of medical devices on October 8th and 9th in Stockholm, Sweden! Take part in an international event dealing with the complexity of regulations and standards for medical devices. The speakers are industry leaders who will provide you with the knowledge and tools you need to simplify complex processes. 🌟Why attend? This is a must-attend conference for professionals involved in product safety, quality, regulatory affairs, design and development, clinical/performance evaluations, post-market clinical follow-up activities, process development, or quality assurance. With insights from industry experts, legal perspectives, patient experiences and notified bodies, the program covers key activities in both the pre- and post-market phases. 🎤Featured Speakers: - Sharmila Gardner, Intertek Medical Notified Body - Pontus Gedda, RISE Research Institutes of Sweden - Anna Kuptel, TÜV SÜD - Richard Holborow, BSI - Judith de Wilde, Axon Lawyers - Erik Hansson, Senior Expert in Global Harmonisation of Medical Device Regulations - Cyrille Michaud, MD101 Consulting - Henrik Eriksson, Swedish Kidney Associate - Sandra Larsson, Technia - Dr. Madlon Timme & Dr. Kristina Then, GBA Medical Device Services - Azadeh Hajipour, GBA Key2Compliance 🔔 Seats are limited! Secure your spot and stay ahead in medical device innovation. You can find the registration link in the comments. We look forward to welcoming you in Stockholm! #GBAGroup #Key2Compliance #medicaldevices

It was great to be invited to speak at MEDICA - Leading International Trade Fair with my colleague Gemma Badger on the theme of making value based healthcare work with an emphasis on the perspective of providers of medical devices and medtech. 🌍 From a number of discussions globally this year there is a clear momentum for the adoption of value based approaches and this will need to be supported by the sectors of healthcare systems (patients, clinical, government/political, devices/pharma/tech, procurement, financial, provision, contracting) to be delivered at scale. 🌍 Again the increasing role of data and analytics in enabling us to understand whether we are delivering on the outcomes that matter to patients is delivering a substantial shift for the contracts/projects which are starting to come through. 🌎 Also the understanding that the outcomes may be wider than those we collect in clinical settings and the use of this data to create learning environments which incentivise collaboration and improvement. 🌏 There are a number of key international experts working on how we move to a more value based healthcare "ecosystem" and projects and evidence are emerging both at a micro and macro scale. Please do let me know if you would like to discuss these themes in more depth. Hill Dickinson Health Lawyers Medilink UK International Services European Association of Value-Based Health Care Jamie Foster Monica Macheng Mark Ratnarajah Steve Barnett Hans Bax 🔵João Marques-Gomes, PhD Sally Lewis Ravi Chana Obafemi Shokoya Hamish Laing Brian Mangan FCIPS James M. Ann Cole Tim Williams Sophia Malik Reem F. Bunyan, MD, MSHA, MS #valuebasedhealthcare #vbh #medica

Welcome to Week 49 of 52 Weeks of WOW: Word of the Week Wednesdays Word of the Week: MEDICAL TRADE ASSOCIATION Medical Trade Association: An organization that serves as a collective voice and advocate for companies within the healthcare industry, representing their interests, promoting collaboration, and advancing the growth and sustainability of the sector. Why is this important? Medical trade associations play a crucial role in fostering collaboration, driving advocacy efforts, and shaping policies and regulations that impact the healthcare industry, contributing to its overall success and advancement. What does the planner need to do? Establish partnerships and collaborate with medical trade associations to leverage their expertise, resources, and networks, and align conference objectives and content with the interests and priorities of member companies. How can planners apply it? By engaging with medical trade associations, planners can gain valuable insights into industry trends, access relevant expertise and resources, and enhance the relevance and impact of their conferences on the healthcare landscape. Key takeaway: Medical trade associations serve as valuable partners and allies in conference planning, offering a wealth of knowledge, connections, and support to help organizers create meaningful and impactful events that address the needs and challenges of the healthcare industry. #52WeeksofWOW #MEDiC #MEDiCseries #pharma #biotech #medicalmeetings #mmp #eventsindustry #meetingsandevents #eventprofs #medcomms #medicalcommunications