We're #hiring a new Sr. Process/Validation Engineer (Contract) in Waltham, Massachusetts. Apply today or share this post with your network.
ECI
Business Consulting and Services
Marlborough, Massachusetts 14,638 followers
Regulatory, Quality, and Engineering Consulting Services to the Life Sciences Industries
About us
Established in 2012, ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena. With a dedicated team of industry professionals, ECI boasts a proven track record in full product life cycle consulting for medical devices, pharmaceutical, biotech, and related industries. Our consultants, with an average of 15 years of experience, form an extensive network of global consultants, providing top-tier quality, regulatory, program management, and engineering solutions. ECI’s comprehensive services and tailored solutions are designed to cater to the unique needs of the dynamic and competitive life sciences market. Our team consists of highly skilled and specialized consultants with proven industry ability in FDA and international regulations, quality management, clinical, research and development, regulatory affairs, post-market activities, quality assurance, technical services, manufacturing processes, product engineering, remediation, and compliance project management. ECI exists to help life science companies keep pace with human need and guide you through your entire product lifecycle challenges. Our headquarters is in Marlborough, MA. We also have an operating office in Alajuela, Costa Rica to serve the LATAM region.
- Website
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http://www.eci-rx.com
External link for ECI
- Industry
- Business Consulting and Services
- Company size
- 51-200 employees
- Headquarters
- Marlborough, Massachusetts
- Type
- Privately Held
- Founded
- 2012
- Specialties
- Project Management, Research and Development, Manufacturing Engineering, Quality, Risk Management, Regulatory, Post Market Surveillance and Vigilance, Mergers & Acquisitions Support, and Technical Services
Locations
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Primary
Get directions
65 Boston Post Rd W
Suite 120
Marlborough, Massachusetts 01752, US
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Get directions
Coyol FTZ
Alajuela, Alajuela 20113, CR
Employees at ECI
Updates
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We're #hiring a new Aseptic Fill / ISO 13408 SME (Contract) in Alajuela, Alajuela. Apply today or share this post with your network.
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👩💼 Conference season remains in full effect and the ECI team is excited to be sponsoring the American Pharma Manufacturing & Outsourcing Summit hosted by Generis in Boston, MA on November 18-19! We can't wait to connect with pharma industry attendees and share how ECI can work collaboratively with your organization to address your specific regulatory, quality, or manufacturing engineering needs. Visit Booth #25 to meet Jeff Kisslinger, MS, MBA, Orla McCullagh-Blount, and Gregory Austin. If interested in scheduling a meetup beforehand, their DMs are open. 👉📩 #USPharma24 #GenerisPMOS
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We're #hiring a new Sr. Process/Validation Engineer in Waltham, Massachusetts. Apply today or share this post with your network.
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ECI reposted this
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
Yesterday, we had a great discussion with our engineering expert, Laura Vargas Agüero on Why Stability & Performance Testing Should Be Separate for Medical Devices and how each test fits into the ISO 11607 regulations. If you didn't get a chance to join us live, take a look at the recording below. We had several good questions and a lively discussion. #medicaldevice #manufacturing #producttesting #packaging #test
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
Join Principal Engineering Consultant, Laura Vargas Agüero and me, as we explore why Stability Testing and Performance Testing for medical devices should be conducted separately, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. We'll dive into the ongoing debate, why some companies haven't changed, and how to align with the new standard to ensure compliance and product safety. #medicaldevice #aging #stability #performance #testing
Why Stability & Performance Testing Should Be Separate for Medical Devices
www.linkedin.com
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We're #hiring a new Engineering Consultant Intern in Alajuela, Alajuela. Apply today or share this post with your network.
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𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗣𝗮𝗿𝗹𝗶𝗮𝗺𝗲𝗻𝘁 𝗖𝗮𝗹𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗥𝗲𝘃𝗶𝘀𝗶𝗼𝗻𝘀 The European Parliament recently held a pivotal planetary session to address the "Urgent Need to Revise the Medical Devices Regulation" (MDR) and In Vitro Diagnostic Regulation (IVDR). Vera Jourova, Vice President of the European Commission, highlighted ongoing measures to ensure the availability of safe, effective medical devices across the EU. Extended transition periods increased notified bodies and a focus on supporting small and medium enterprises (SMEs) are already delivering improvements. At ECI, we recognize the vital role of the regulatory framework to support innovation and patient safety. Efforts to provide a streamlined regulatory process with transparent and binding timelines have the potential to contribute to a sustainable healthcare landscape. We look forward to supporting our clients through the ongoing transitions and ensuring they are well-prepared for the evolving regulatory environment. 👉 Learn more: https://www.eci-rx.com/ #MedicalDevices #Regulation #LifeSciencesConsulting
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ECI reposted this
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
A friendly reminder that I will be hosting a LinkedIn Live event today at 12pm ET, 11am CT on the best Medical Device Testing methods with our wonderful Principal Engineering Consultant, Laura Vargas Agüero! I hope to see you there! #medicaldevice, #testing, #engineering
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
Join Principal Engineering Consultant, Laura Vargas Agüero and me, as we explore why Stability Testing and Performance Testing for medical devices should be conducted separately, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. We'll dive into the ongoing debate, why some companies haven't changed, and how to align with the new standard to ensure compliance and product safety. #medicaldevice #aging #stability #performance #testing
Why Stability & Performance Testing Should Be Separate for Medical Devices
www.linkedin.com
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We're #hiring a new IT Desktop Support Intern in Alajuela, Alajuela. Apply today or share this post with your network.
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Why should stability and performance testing be separate for medical devices? Join ECI for an insightful discussion on Tuesday, October 29th, at 12:00 PM EDT as Laura Vargas Agüero and Gregory Austin explore reasons why, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. Learn how to align with the new standard to ensure compliance and product safety. 📅 Tuesday, October 29, 2024 ⏰ Time: 12:00pm EDT 💡 Interactive Q&A session 👉 Join here: https://lnkd.in/em8_hHhs #medicaldevice #performance #stability #testing
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
Join Principal Engineering Consultant, Laura Vargas Agüero and me, as we explore why Stability Testing and Performance Testing for medical devices should be conducted separately, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. We'll dive into the ongoing debate, why some companies haven't changed, and how to align with the new standard to ensure compliance and product safety. #medicaldevice #aging #stability #performance #testing
Why Stability & Performance Testing Should Be Separate for Medical Devices
www.linkedin.com