In the ever-evolving landscape of the medical device industry, having a solid regulatory strategy is crucial for success. Read the article to learn more.
NSF - Life Sciences
Business Consulting and Services
Ann Arbor, Michigan 14,794 followers
NSF provides world-class consulting, training, clinical, and auditing services to the life sciences industry
About us
NSF works with pharmaceutical, medical devices, and in vitro diagnostic companies, large and small, to provide highly customized end-to-end services throughout the product lifecycle, from clinical trials to post-market surveillance. We are a global provider of clinical trials, training, consultancy, certification and auditing services to the health sciences industry. We have an outstanding international reputation in quality management and regulatory compliance. We provide comprehensive solutions for the health sciences industry from experts you can trust. Our team includes former FDA, EU and MHRA regulators as well as industry experts. We combine regulatory knowledge with industry best practices to provide our clients with tailored quality, compliance and regulatory services About NSF For more than 75 years, our mission has remained the same: protect and improve human health. Our Values Building a healthy culture and looking after our people is fundamental to achieving our mission—and underpinning everything we do. Everything, not least client focus and growth, is built upon this. Our culture starts with four core values: Do the Right Thing; Treat People Well, Relentlessly Pursue Excellence, and We Are One NSF. These core values are the principles that guide all of NSF’s actions. Work at NSF - careers - https://www.nsf.org/about-nsf/careers
- Website
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https://www.nsf.org/life-sciences
External link for NSF - Life Sciences
- Industry
- Business Consulting and Services
- Company size
- 5,001-10,000 employees
- Headquarters
- Ann Arbor, Michigan
- Type
- Nonprofit
- Founded
- 1944
- Specialties
- Clinical Trials, Product Lifecycle Support, Regulatory Strategy, Market Access, Regulatory Compliance Consulting, QMS Improvement, GMP Certification, Product and Ingredient Certification, Auditing and Inspections, Training and Education, Corporate Due Diligence, Remediation, Leadership Development and Coaching, Facilities, Equipment and Technical Support, and Post-Market Surveillance
Locations
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Primary
Get directions
789 N Dixboro Rd
Ann Arbor, Michigan 48105, US
Employees at NSF - Life Sciences
Updates
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Following the tremendous success of our UK Conference in 2023, we are excited to announce the date and high-level agenda for NSF’s 2nd UK Conference. This year the Conference will again be held in the RSC in London. We have invited and confirmed speakers from Regulatory Authorities, Trade Associations, and Industry. This includes, UK MHRA, EMA, US FDA, ABPI, BGMA, and Pharma. The two themes of the event are: Supply disruption/resilience challenges & opportunities and AI & Technology Advancements in Manufacturing. We anticipate this to be another sell-out event with excellent attendance from the pharma-biotech sector (C-suite, Senior Leaders Quality Representatives and Consultants from big pharma, SMEs, and Start-ups). Save the date - registration goes live next week.
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What is the most important thing to do to prepare for an inspection? Dave Waddington, Executive Director at NSF gives his advice on Expectations from a Regulatory Inspection. Watch the informative webinar here: https://bit.ly/3LFWR5W
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NSF's certification helps private label products thrive and opens doorways to new markets. Read the full guide here: https://bit.ly/3A73ICz
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Unlock Success with NSF & University of Strathclyde's MSc in Pharmaceutical Quality and Good Manufacturing Practice https://bit.ly/4faHL5X
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Online supplement shopping is hotter than ever. NSF's free online shopper report shares consumer attitudes on quality, safety, convenience, and cost. Read the free guide: https://bit.ly/3LBkAUE
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Questions about Amazon’s Dietary Supplement Policy? NSF's FAQ webinar is here to help! Register here: https://bit.ly/4bWdox1
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In this extract from the NSF white paper on the Quality Management Maturity model, experts explain how they worked with a pharmaceutical company to deploy QMM across global sites. Learn more about this Knowledge Library article here: https://bit.ly/3WdME5v
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🔍 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 We recently polled the community to uncover the biggest challenges in managing technical documentation within the medical device sector. Here’s how you responded: • Regulatory Compliance Updates: 24% • Limited In-house Expertise: 29% • 𝗟𝗮𝗰𝗸 𝗼𝗳 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝗹 𝗕𝗮𝗻𝗱𝘄𝗶𝗱𝘁𝗵: 𝟯𝟱% • Document Management Systems: 12% 📊 𝗪𝗵𝘆 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿𝘀: The prominence of ‘Lack of Internal Bandwidth’ highlights a critical gap in resource allocation for documentation management, essential for compliance and operational efficiency. This challenge, along with limited in-house expertise, underscores an urgent need for strategic interventions and possibly external support to maintain high standards in documentation practices. 💡 𝗢𝘂𝗿 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲: The poll underscores the importance of addressing these challenges to maintain efficient operations and compliance. Building internal expertise is crucial. Training and competency building ensure that all team members are knowledgeable about regulatory requirements and best practices. We understand that navigating these complexities often requires balancing internal capabilities and strategic outsourcing. 🌐 𝗛𝗼𝘄 𝗡𝗦𝗙 𝗖𝗮𝗻 𝗛𝗲𝗹𝗽: Manufacturers can leverage our extensive experience and industry knowledge by partnering with NSF to enhance their technical documentation processes. Outsourcing your global technical documentation and regulatory compliance tasks to NSF saves time, reduces costs, and mitigates risks associated with non-compliance. Our expert team ensures your documentation meets the current state-of-the-art, paving the way for successful market entry and sustained product performance. 🤝 Join the Conversation: How is your organization managing these challenges? Share your strategies by joining the discussion below. #MedicalDevices #TechnicalDocumentation #Compliance