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.
External link for ECI
65 Boston Post Rd W
Suite 120
Marlborough, Massachusetts 01752, US
Coyol FTZ
Alajuela, Alajuela 20113, CR
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Good morning friends! Make every morning even better by joining our team as Director of Business Development (life sciences experience required). We are building something special! Apply at the link below.
We're #hiring a new Director of Business Development in Marlborough, Massachusetts. Apply today or share this post with your network.
ECI is sponsoring the American Pharma Manufacturing & Outsourcing Summit hosted by Generis in Boston, MA on November 18-19. Come meet our team to discuss how ECI can help you navigate your regulatory, compliance, engineering, and quality needs throughout the entire product lifecycle. We look forward to meeting and catching up with attendees in person. #USPharma24 #GenerisPMOS
We'd like to invite you to join Laura Vargas Agüero, Principal Engineering Consultant, and Gregory Austin, Business Development Lead, on Tuesday, October 29th, for our upcoming ECI Live. 𝗪𝗵𝘆 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗦𝗵𝗼𝘂𝗹𝗱 𝗕𝗲 𝗦𝗲𝗽𝗮𝗿𝗮𝘁𝗲 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 Join us as Laura and Gregory explore why stability 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. Laura and Gregory will dive into the ongoing debate, why some companies have not made a change, and 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 #testing #stability
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
We're #hiring a new Regulatory IVD/IVDR/CDx SME (Adhoc) in Marlborough, Massachusetts. Apply today or share this post with your network.
ECI reposted this
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
We're #hiring a new Project Manager (Medical Device Experience) in Stevensville, Michigan. Apply today or share this post with your network.
We're #hiring a new Director of Business Development in Marlborough, Massachusetts. Apply today or share this post with your network.
We're #hiring a new Director Of Business Development in United States. Apply today or share this post with your network.
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Day 1 of the American Medical Device Summit in Chicago, IL. Stop by the Delegate Lounge to speak with our team about how we can support your regulatory, compliance, engineering, and quality needs throughout the product lifecycle. #medicaldevices #lifesciences #consulting
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We just closed out another great show at the Generis American Medical Device Summit in Chicago. It was a whirlwind of connections and discussions with medical device industry leaders and fascinating sessions on hot topics in the industry. I had the honor of presenting “Best Practices in Successful Product Design Acquisition Integration” with my fabulous colleagues Shital Patel and Maylin (May) Truesdell. This is a topic that we are passionate about at ECI and hope that organizations can benefit by following the roadmap we provided or engaging with us to support their acquisitions. On a personal note, this is my favorite type of project! It was also great to connect in real life with our local team members in the Chicago area. Lots of laughs and such a good time! I’m already looking forward to next year! #AMDSummit #ECI #enhancedcompliance #quality #regulatoryaffairs #engineering #medicaldevices #consulting