Product Development Outsourcing Needs Speed, Safety & Certainty
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4 FAQs to Notified Bodies
Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.
Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence
To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.
Japan Reimbursement (Part 2): How to increase Japan reimbursement after receiving initial Japanese pricing
Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device companies want to register their devices quickly in Japan to be on the market and are not focused enough on the initial medical device reimbursement they will get. This can lead to an unprofitable business if the Japanese reimbursement price is not higher than the sales price in Japan. Are there strategies to increase reimbursement?
Japan Reimbursement (Part 1): What do you need to know about getting your medical device reimbursed in Japan?
Medical Devices must be fully reimbursable – no out of pocket expenses – in Japan. So, how is reimbursement achieved for your medical device?
AI and Automation Tools: Medical Writers’ Point of View
EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help?
Ask the Expert: Is Your MedTech Company Considering a Regulatory RIM Platform?
Misconceptions about using Regulatory Information Management (RIM) platforms to manage MedTech regulatory workflows. Here, we Bust 3 Naysayer Myths.
Ask the Expert: PMCF implementation under EU MDR
Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).
Ask the Expert: What is Regulatory Excellence in the Medical Technology World?
Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.
Ask the Expert: Harnessing the Potential of Digital Quality – Transforming Manufacturing Outcomes for Long-Term Success
Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.
