#GlobalRegulatoryUpdatesWithRegDesk 🌐 Join RegDesk for our latest Global Regulatory Updates. This week our 2-minute video shares important alerts from South Korea, Pakistan, and Taiwan/Japan. This week's top global regulatory updates include: 1. South Korea: Guidinace on Minor Change Reporting for Medical Devices 2. Pakistan: Implementation of Industry E-Reporting System for Adverse Drug Reactions by Registration Holders 3. Taiwan/Japan: Question and Answer for Product Registration Process for Medical Device in Taiwan and Japan Watch the video for more details! 👉 Follow RegDesk to stay up to date with our Medical Device Regulation Alerts. #RegulatoryUpdates #RegDesk #Compliance #SouthKorea #Pakistan #Japan #Taiwan #RIMS #MedicalDevices #Regulations
RegDesk
Software Development
Houston, TX 10,183 followers
The Most Comprehensive AI Enabled RIMS For MedTech Companies
About us
RegDesk transforms the way healthcare leaders make decisions. Our holistic Regulatory Information Management (RIM) system delivers cutting-edge intelligence solutions to help compliance leaders stay one step ahead of regulatory risks and changes globally. With RegDesk, you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Don't let regulatory changes become a roadblock. Global expansion has never been this simple.
- Website
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https://www.regdesk.co/
External link for RegDesk
- Industry
- Software Development
- Company size
- 51-200 employees
- Headquarters
- Houston, TX
- Type
- Privately Held
- Founded
- 2014
- Specialties
- Regulatory, Quality Management Systems (ISO 13485, 21 CFR 820), Validation, Verification Protocols & Reports, Clinical Testing, HIPPA, Quality Assurance, Compliance, Medical Device, Pharmaceutical, Submission Generator, Tracking and Reporting, Change Assessment, Standards Management, GSPR, Regulatory Intelligence, Regulatory Affairs, Distributor Collaboration, Document Management, Alerts and Notifications, Product Management, RIMS, Healthcare, and Diagnostics
Locations
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Primary
Get directions
2450 Holcombe Blvd
Suite X
Houston, TX 77098, US
Employees at RegDesk
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Priya Paul (Bhutani)
Founder & CEO, RegDesk.co
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Claudia Carolina Mayer
Regulatory Affairs Specialist | Medical Devices | IVD | Quality Management | ANVISA RDC 665/2022 | ANVISA RDC 751/2022 | ANVISA RDC 830/2023 |…
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Matt Winters
Enterprise Sales Team Lead
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Pablo Ojeda
Medical Devices QA/RA Specialist | Enhancing Quality and Compliance through R&D and Innovation
Updates
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#GlobalRegulatoryUpdatesWithRegDesk 🌐 Join RegDesk for our latest Global Regulatory Updates. This week our 2-minute video shares important alerts from Australia, Canada, and Taiwan. This week's top global regulatory updates include: 1. Australia: Amendments to Regulation 2002 2. Canada: A Consolidation of Medical Device Regulations has been Published 3. Taiwan: Application Instructions for Foreign Medical Device Manufacturer QSD Inspection Watch the video for more details! 👉 Follow RegDesk to stay up to date with our Medical Device Regulation Alerts. 🎤What countries are most important for your company? We would love your feedback on which countries you want to hear more about. #RegulatoryUpdates #RegDesk #Compliance #Australia #Canada #Taiwan #RIMS #MedicalDevices #Regulations
Global Regulatory Updates from Australia, Canada and Taiwan
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🌟 Happy Diwali! 🌟 As many of our team celebrates the Festival of Lights, let's take a moment to reflect on the themes of hope, renewal, and unity that Diwali brings. This time of year reminds us of the importance of coming together, supporting one another, and embracing the light amidst challenges. Let’s continue to spread positivity and collaborate towards a brighter future together! Wishing everyone a safe and joyful Diwali! 🪔✨ #Diwali #FestivalOfLights #Gratitude #RegDesk #RegulatoryAffairs #Collaboration
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RegDesk is hiring. See below for more details about working for a great company.
Medical Devices & IVDs Compliance || MD & IVDs Standards || Drugs & Biologics || Regulatory Intelligence || Regulatory Strategics Management || MedTech Industry
RegDesk 𝗶𝘀 𝗛𝗶𝗿𝗶𝗻𝗴! 𝐂𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐧𝐠 𝐃𝐫𝐞𝐚𝐦𝐬 𝐭𝐨 𝐉𝐨𝐛𝐬!! 𝐆𝐫𝐚𝐛 𝐨𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐨𝐦𝐚𝐢𝐧! Interested candidates apply to 𝐚𝐩𝐮𝐫𝐯𝐚.𝐛𝐡𝐚𝐫𝐝𝐰𝐚𝐣@𝐫𝐞𝐠𝐝𝐞𝐬𝐤.𝐜𝐨 and with subject line "Application for Regulatory Intelligence Associate-Medical Devices." 𝐏𝐨𝐬𝐢𝐭𝐢𝐨𝐧: "Regulatory Intelligence Associate" 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Mohali, India (On-Site Only) 𝐄𝐝𝐮𝐜𝐚𝐭𝐢𝐨𝐧: M.Pharm/MSc in regulatory affairs or equivalent 𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐚𝐧𝐝 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬: M.Pharm/MSc in regulatory affairs or equivalent hashtag #RegDesk: RegDesk is a leading AI-enabled regulatory information management software (RIMS) for medical device, diagnostic, and pharmaceutical companies. It allows regulatory affairs teams to prepare, manage, and publish international submissions and gain approval within unprecedented timelines. 👉 Minimum 𝟏-𝟑 𝐲𝐞𝐚𝐫𝐬 of experience in medical device regulations/submissions. 👉 Shall have expertise with global registration/dossier submission. 👉 Able to multitask effectively and work independently with international oversight. 👉 Must have expertise in international regulations for medical device regulations. 👉 The candidate must demonstrate the ability to summarize regulatory data effectively. 👉 The candidate must be able to source highlights from the regulatory information and present them in a simplified format. 👉 Source and synthesize the regulatory laws. 👉 Keep an eye on changes to regulatory updates/changes. 👉 Communicate directly with the international affiliates and the regulatory intelligence team. 👉 Team player with high energy, a cheerful personality, and a proactive or go-getter attitude. 👉 Proficient in English speaking and writing. #medicaldevices #registration #regulatoryintelligence #eumdr #ivdr #mohali #job
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#RegulatoryUpdatesWithRegDesk 🌐 In Saudi Arabia, MDS G002 Guidance on Innovative Medical Devices specifies the designation criteria for innovative medical devices, associated review processes, and the features of the pathway to outline the requirements for applying through the innovative medical devices pathway and explains the submission process. Version 3/24000 Follow: 👉RegDesk to get your Global Regulatory Updates! #regulatoryupdates #RegDesk #compliance #SaudiArabia #guidance #regintel #alerts
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🖥️ We recently hosted a webinar on Navigating Cybersecurity Challenges and Compliance. Priya Paul (Bhutani) was joined by special guest panelists Christy Mazzarisi, MSRAQA, Gabriel Pascualy, and Jason Vanzin, who shared invaluable insights on key cybersecurity topics, including: -Understanding the Evolving Cybersecurity Threat Landscape -Navigating Regulatory Cybersecurity Requirements -Adapting to the Shifting Cybersecurity Threat Landscape -Establishing Effective Cybersecurity Protocols -Implementing Effective Cybersecurity Protocols -Responding to Cybersecurity Incidents and Ensuring Continuity -Proactive Cybersecurity Incident Management and Recovery You can watch it here if you missed it: https://lnkd.in/egbUa3Wp Their expertise offered a comprehensive view on how companies can stay ahead in today’s ever-changing cybersecurity environment, so be sure to check it out! #Cybersecurity #RegulatoryAffairs #RiskManagement #MedTech #Compliance #IncidentManagement
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#RegulatoryUpdatesWithRegDesk On October 23, 2024, the European Parliament plenary voted the Resolution on the urgent need to revise the Medical Device Regulation. MedTech Europe welcomes the European Parliament’s call for measures to address the most pressing challenges and bottlenecks in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) by early 2025. Follow: 👉RegDesk to get your Global Regulatory Updates! #RegDesk #EU #Medtech #RegUpdates #compliance #topalerts #MDR #IVDR
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#GlobalRegulatoryUpdatesWithRegDesk 🌐 Join RegDesk for our latest Global Regulatory Updates. This week our 2-minute video shares important alerts from Tanzania and Czech Republic. This week's top global regulatory updates include: 1. Tanzania: New Guidelines for Control of Medical Devices and Diagnostics 2. Czech Republic: Year-on-year increase in reimbursement of medical devices for 2024 👉 Follow RegDesk to stay up to date with our Medical Device Regulation Alerts. 🎤We want to hear from YOU! Help us tailor our content to better suit your company's needs! 🌍 In which countries have you registered your medical devices? Let us know in the comments or send us a message—your input helps us provide more relevant and impactful information! #GlobalRegulatoryUpdates #RegDesk #GlobalCompliance #MedicalDevices #RegAlerts #Tanzania #CzechRepublic
Global Regulatory Updates: Tanzania and Czech Republic
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#TeamMemberSpotlight 🔦 We’re thrilled to highlight one of our amazing team members this month! ELISEO ANGULO VIURCOS has been a valued part of the RegDesk team for 1 year and 9 months. At RegDesk, we take great pride in our talented team, and Eliseo's hard work and dedication truly stand out. His positive energy and commitment help make our company a great place to work. Thank you, Eliseo, for all that you do to contribute to our success! Your efforts are truly appreciated! 👏 #TeamSpotlight #RegDesk #AI #Innovation #TeamMemberAppreciation #BestTeam #RIM
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