Platomics

Team Platomics will be in Paris at Forum LABO from March 25-27, 2025! Catch us in the crowd or make it easy and schedule a meeting with us: https://lnkd.in/dSDsmeWe We are happy to chat about how Platomics can support IVD manufacturers and labs by making compliance easier. #ivdr #forumlabo Pierre Bect Clara Pessy

Catarina Veiga and Michael Wittinger from Team Platomics will be at the World CB&CDx Summit in London! Ask us about how IVDR compliance of clinical trial labs impacts pharma—and how we can help. Come to the session moderated by Catarina Veiga on “Navigating IVDR: Biomarker Test Compliance in Clinical Trials.” on Thursday 10th April, 2025 at 11:20 AM BST. Find out more about Platomics’ Pharma Initiative: https://lnkd.in/ddwEZfCM Or schedule a meeting with our experts: Book a Meeting with Michael: https://lnkd.in/d--29fmr Book a Meeting with Catarina: https://lnkd.in/dvnhKr3a

Verification and validation in the clinical lab: When do I need which? ISO 15189 and IVDR Article 5.5 both have something to say about it. Our latest blog post explains. With all the new requirements, many of the labs we work with are unsure about when and how they need to verify and validate workflows or devices used in the lab. So we created a blog post that provides orientation. Read the blog post here: https://lnkd.in/dp9pjrxU #ivdr #regulatory #clinicallabs

Very happy to announce the latest innovative manufacturer on the Platomics platform: biocrates life sciences ag, a global leader in quantitative metabolomics, and Platomics announce a strategic collaboration to support laboratories with ensuring and documenting the quality of their workflows with biocrates metabolomics solutions. Moritz Seuster, CEO of biocrates life sciences ag: “Partnering with Platomics is a pivotal step in our mission to make metabolomics accessible. By bringing our kits onto the PlatoX® platform, we’re empowering laboratories to quickly adopt accurate quantitative metabolomics and document the quality of their work – ultimately leading to better results and more insights on every sample.” Read the press release: https://lnkd.in/dY2afDJX #regulatory #clinicallabs #IVDR

IVDR 2.0 is unlikely to ease the regulatory burden on EU labs. One solution: Reframe the burden as a competitive advantage and look to digital solutions that make demonstrating quality and patient safety easier. Read all about it in the French La Gazette du LABORATOIRE here: https://lnkd.in/dab4m2Ws Or read an English summary here: “To Document or not to Document GSPRs? That is the Question for Laboratories” (Marie Salin in “La Gazette DIAG&SANTÉ,” February 17, 2025) • GSPR and IVDR Compliance: The General Safety and Performance Requirements (GSPR) form the core of IVDR compliance, requiring laboratories to document the safety and performance of their in-house tests. • Technical Documentation Requirements: GSPR documentation covers three key areas—safety and performance, design and manufacturing and labeling/information. Included therein: Risk management and analytical and clinical performance evaluation. • Challenges of Documentation: Laboratories must choose between paper-based (traditional but cumbersome) or digital documentation (efficient but requiring validation). • Common Compliance Pitfalls: Mistakes include applying a one-size-fits-all approach, meeting only minimal compliance, or failing to document at all—each posing risks during audits. • Best Practices for GSPR Compliance: Labs may group similar tests, use structured templates while allowing flexibility and adopt digital solutions for better efficiency and traceability. • Future of IVDR for Labs: A regulatory "IVDR 2.0" revision is unlikely to ease laboratory burdens. Instead, the trend is rather toward stricter enforcement, making proactive lab compliance essential. • Compliance as a Competitive Advantage: Rather than a bureaucratic hurdle, structured compliance can enhance quality, patient safety and long-term operational stability. Find out more about what Platomics is up to, including our next French-language webinar: https://lnkd.in/dTJaJ3EQ #IVDR #IVDReady #clinicallabs #regulatory

Don’t miss Platomics' very own Ruth Mahfoozpour speaking about the legal context of RUOs at the en.co.tec - Medizinprodukte-Consulting & Akademie Online-Forum Roundtable titled “Regulatory Update on Medical Devices and In Vitro Diagnostics”! All you need to know about the legal ins and outs of RUOs in the IVD context—concisely presented in this German language webinar. Research Use Only Produkte im rechtlichen Kontext Beim en-co-tec Online-Forum Roundtable: Regulatory Update für Medizinprodukte & In-vitro Diagnostika Dienstag, 11. März 2025 9:00-11:00 CET Register for the talk: https://lnkd.in/dFDcZQeG Platomics is transforming Regulatory for in vitro diagnostics: https://lnkd.in/dcJ64j7h #IVDR #IVDReady #medicaldevices

4bases and Platomics partner up to facilitate laboratory workflow documentation. Feb 25, 2025 | Manno, Switzerland, and Vienna, Austria – 4bases and Platomics are delighted to announce a strategic agreement aimed at facilitating laboratory regulatory documentation. Clinical laboratories using 4bases products can now efficiently navigate regulatory documentation on Platomics’ PlatoX® platform. Read the press release: https://lnkd.in/dJ9Cy3jY #IVDR #clinicallabs #regulatory

ISO 5649: Just more regulatory work for already strained EU labs? Or perhaps a beautiful standard that can help make art out the chaos of regulatory requirements? Our latest blog post shows how this new global standard for LDTs points the way toward IVDR compliance—and how our platform enables your lab to painlessly implement its benefits. Platomics—Transforming regulatory science into an art. Read the blog post: https://lnkd.in/dZ8ZSPRT #IVDR #clinicallabs #regulatory

Regulatory ratatouille for labs – What needs to go in the pot? French language webinar on IVDR, ISO 15189 and Co. ISO 15189 is just one ingredient in the complex recipe for IVDR compliance. Labs with in-house IVDs require a ratatouille-like blend of regulatory ingredients that overlap and must work together in one pot. This webinar informs labs about IVDR requirements and the relevant standards with which they intersect. We offer practical advice on the most efficient way to demonstrate the quality and compliance of your lab. Ratatouille réglementaire au labo : IVDR, ISO 15189 et cie 8 avril 2025 15h30-17h00 CET (Vienne) Register for the webinar: https://lnkd.in/dPbWJqgZ #IVDR #IVDReady #clinicallabs #regulatory

Breaking news: Platomics' partnerships with Agilent Technologies and SOPHiA GENETICS have been spotlighted in GenomeWeb! This recognition marks another milestone in our collaborative mission to deliver innovative regulatory solutions for laboratories. A big thank you to our incredible team and partners for making this possible! Read the full story here: https://lnkd.in/dRiMSdui Platomics is transforming #Regulatory for in vitro diagnostics: https://lnkd.in/daM5ZPfG #IVDR #IVDReady #clinicallabs #NGS