🚀 Exciting News! We are thrilled to #announce that RegTrac is now a proud #member of Science & Engineering Health Technologies Alliance (SEHTA). #SEHTA is a #global MedTech network with over 1,500 members, dedicated to transforming #healthcare through #innovation, #collaboration, and #excellence. RegTrac is part of this vibrant #network, joining a community of #experts, #organizations, and #thought leaders, including esteemed SEHTA partners such as London Institute for Healthcare Engineering, Bidshaper, Health Innovation Kent Surrey Sussex, Medilink UK International Services, Hill Dickinson LLP, ORCHA and Psephos Biomedica. Thank you Neil Roberts, David Tuch and Clare Ansett for all the support! Let’s #innovate, #collaborate, and #transform the #MedTech landscape together! 🌍 #RegTrac #regulatory #medicaldevices #healthcareinnovation
About us
RegTrac is a trusted Healthcare Regulatory Partner for navigating the complex landscape of Global Regulatory Affairs, Quality Systems and Compliance, with expert guidance. Whether it is Medical Devices, Cosmetics or Consumer Products, where regulatory requirements are stringent and vary significantly across different markets, our expertise is your competitive advantage and unlock the global potential for your business. RegTrac insights & experience will build confidence for MedTech Companies to innovate and expand your global reach while staying compliant to healthcare regulations. Why Choose Us? 🚀 🌟 Global Regulatory Ninjas: We're masters of the EU, US and global markets – from Africa to Asia including Middle East & Australia, we've got the know-how to steer you through every regulatory hurdle. 🌟 All-in-One: Strategic expertise to Regulatory insights to Compliance mastery. We've got you covered from start to finish, ensuring you hit every milestone on the path to success. 🌟 Spot On: We’re all about getting it right the first time. Say “goodbye” to delays and “hello” to accelerated regulatory approvals! 🌟 Skills Boost: Whether you're just starting out or a seasoned pro, our training programs in Regulatory Affairs are designed to level up your game. Gain insights from industry pros and master the ins & outs of regulations with practical know-how. Let's explore and start planning! 📩 Ready to simplify your path to global success? Reach out to us at [email protected] and let's set sail for greatness together. 🌟 Specialties: Regulatory Affairs, Quality Systems, Compliance
- Website
-
https://www.reg-trac.com
External link for RegTrac
- Industry
- Business Consulting and Services
- Company size
- 2-10 employees
- Headquarters
- Woking, UK, Surrey
- Type
- Privately Held
- Founded
- 2018
- Specialties
- Regulatory Affairs, Quality Management Systems, MedTech Solutions, Consumer Healthcare, Cosmetics, Medical Devices, Regulatory Compliance, Invitro Diagnostic Devices, ISO 13485 Certifications, Global Registrations, UKRP, PRRC, European Authorised Representative (EAR), CH-REP, EU Regulations, EU MDR, EU IVDR, UK MDR, Global Regulations, EU Cosmetics, Healthcare Regulatory, MDR Transition, Identification of Notified Bodies, CE Certification, and Responsible Person
Locations
-
Primary
Get directions
Send Business Centre
3, Tannery House, Tannery Lane, Send
Woking, UK, Surrey GU23 7EF, GB
-
Get directions
Nelson Manickam Road,
Nelson Towers, 4th floor, Wing-4,
Chennai, Tamil Nadu 600 029, IN
-
Get directions
Workhub, 51 Bracken Road, Sandyford
Dublin, Leinster D18 CV48, IE
Employees at RegTrac
-
Dr Nisha Vempalle
Leader with Passion for People | Regulatory Strategist | Global Regulatory Specialist | Med Tech & Digital Innovation | Medical Devices & IVD…
-
Abhinaya Muralidharan
Trainee @RegTrac | Content Creator | Writer |
-
Monideepa Guha
Strategic Account Executive- Regulatory Affairs @ RegTrac | Medical Devices | Cosmetics | Project Manager | Consulting
-
Adarsh Anand, RCC-MDR
Healthcare Product Compliance Professional | Regulatory Affairs & Quality Assurance | R&D Enthusiast | Software Fanatic
Updates
-
📜Symbol Saturday: Paraxial back vertex power The symbol “Paraxial back vertex power” denotes measurement of a contact #lens optical power at its #paraxial (central) region for ensuring the lens provides the correct #refractive correction for the wearer’s #prescription. RegTrac offers #Labelling and #Artwork services to #medicaldevice manufacturers. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #ISO #Symbols #RegTrac #regulatorycompliance #packaging #symbol #patientinformation #traceability #eumdr #ISO18369 #opticalpower #diopter
-
🗞 Find out Friday: ISO 12818:2013 ISO 12818:2013 defines the #tolerances for bottles designed for use in #pharmaceutical, #cosmetic, #perfumery and #chemical products. 👇 Check out the video carousel to know more. RegTrac offers #QMS and #regulatory support for #medicaldevices, #invitrodiagnostics, #SaMD, #CDx & #cosmetics. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #iso #iso12818 #regtrac #regulatorystandards #bottles
-
📜Symbol Saturday: Total Diameter The symbol “Total Diameter” denotes the overall #diameter of contact #lenses for appropriate selection that match the wearer’s #corneal size and curvature, avoiding #discomfort or #vision issues. RegTrac offers #Labelling and #Artwork services to #medicaldevice manufacturers. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #ISO #Symbols #RegTrac #regulatorycompliance #packaging #symbol #patientinformation #traceability #eumdr #ISO18369
-
🗞 Find out Friday: ISO 18818:2017 ISO 18818:2017 applies to #cosmetic product #manufacturers (including #skincare, #haircare, #makeup, #toiletries, and #personalcare products) requiring testing for #diethanolamine levels to meet #safety and #regulatory standards. 👇 Check out the video carousel to know more. RegTrac offers #QMS and #regulatory support for #medicaldevices, #invitrodiagnostics, #SaMD, #CDx & #cosmetics. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #iso #iso18818 #regtrac #regulatorystandards
-
The "Wear Eye Protection" symbol is displayed on devices or in areas where there is a risk of #eye injury due to exposure to harmful light, flying particles, or chemical splashes, such as during #laser surgery, #xray scans or #sterilization processes. 👇Watch the video carousel to know more. RegTrac offers #Labelling and #Artwork services to #medicaldevice manufacturers. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #regulatorycompliance #packaging #symbol #patientinformation #traceability #eumdr #ISO7010 #goggles #spectacles #safety
-
🗞 Find out Friday: ISO 18416:2015 ISO 18416:2015 applies to #cosmetic product #manufacturers (including #skincare, #haircare, #makeup, #toiletries, and #personalcare products) requiring testing for Candida albicans #contamination to meet #safety and #regulatory standards. 👇 Check out the video carousel to know more. RegTrac offers #QMS and #regulatory support for #medicaldevices, #invitrodiagnostics, #SaMD, #CDx & #cosmetics. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #iso #regtrac #regulatorystandards #iso18416
-
🤖 Latest Position Paper from #TeamNB: AI in Medical Devices Team-NB has released a #positionpaper and #questionnaire on the application of Artificial Intelligence (#AI) in medical devices, aligning with the #MDR and #IVDR frameworks. 👉 For more information, check out this link: https://lnkd.in/dZvvMcDJ RegTrac is here to support your regulatory needs in #IVD & #MedTech. Book a meeting with us at [email protected] | www.reg-trac.com #europeancommission #artificialintelligence #medicaldevices #invitrodiagnostics #regulatoryguidance #regulatoryupdate #regulatorycompliance #notifiedbody
-
📑 Regulatory update from #EU: Attention #MedTech professionals! The Directorate-General for Health and Food Safety Policy Department of the European Commission has released a Q&A document addressing practical aspects of the gradual roll-out of #EUDAMED under the #MDR and #IVDR. This Q&A document is intended to facilitate the application of Regulation (EU) 2024/1860 of the European Parliament and of the Council of the European Union of 13 June 2024 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). 👉 Read the complete guidance here: RegTrac is here to support your regulatory needs in #IVD & #MedTech. Book a meeting with us at [email protected] | www.reg-trac.com #regulatoryupdate #regulatorycompliance #eu #europeancommission #regulations #guidance #faq
-
📜Symbol Saturday: Warning - Electricity The symbol “Warning: Electricity” is used to #warn individuals about the presence of electrical #hazards that could result in #shock, #burns, or other #injuries. RegTrac offers #Labelling and #Artwork services to #medicaldevice manufacturers. Reach out to us at [email protected] or visit www.reg-trac.com to schedule a 30-minute consultation with our experts. #ISO #Symbols #RegTrac #regulatorycompliance #packaging #symbol #patientinformation #traceability #eumdr #ISO7010 #danger #protection #hazard #safety #electricity