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🌎 Gene Therapies in Chile: Overcoming Regulatory Gaps

Obtaining ISO 13485 certification is a critical process for medical device companies. It involves careful planning, developing quality systems, and overcoming various challenges.

Key Points:

  • Understand ISO 13485 principles like customer focus and continuous improvement
  • Plan and develop a comprehensive quality management system
  • Conduct gap analyses to identify areas needing improvement
  • Train employees and foster a culture of quality throughout the organization
  • Address common challenges like documentation issues and resource constraints

Why It Matters: Achieving ISO 13485 certification demonstrates your commitment to quality and safety, giving you a competitive edge in the medical device industry.

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🧪 New Pharma Rules Reshape Global Clinical Trials

Clinical trials are complex but crucial for advancing medical treatments. Understanding the process, planning effectively, and engaging participants are key to success.

Key Points:

  • Clinical trials progress through four main phases, each with specific goals
  • Careful planning and execution are essential for trial success
  • Site selection and regulatory approvals play critical roles
  • Effective recruitment strategies boost participant engagement
  • Ongoing communication maintains participant commitment throughout the study

Why It Matters: Mastering these elements can accelerate the development of life-changing treatments while fostering economic growth in emerging research hubs.

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🚀 Launching Globally: Your 60-Day MedTech Trial Roadmap

Join us as we delve into the journey of Julio G. Martinez-Clark, co-founder and CEO of bioaccess®, a U.S.-based Contract Research Organization (CRO) revolutionizing medical technology access in Latin America. Discover how Julio's innovative approach is accelerating first-in-human and early feasibility studies, offering 40% faster approvals and 30% lower costs for MedTech and Biopharma companies.

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🌎 Simplifying Global Medtech Trials: Colombia to Albania

Julio Martinez-Clark, CEO of bioaccess®, shares his insights on the current state of the Medtech industry in a podcast interview with Adam Torres. The discussion delves into the trends shaping this rapidly evolving sector.

Key Points:

  • Julio Martinez-Clark offers expert perspective on Medtech trends
  • The podcast explores the CEO's professional journey in the industry
  • Current challenges and opportunities in Medtech are discussed
  • Insights into future directions for medical technology are shared
  • The interview provides valuable information for industry professionals

Why It Matters: This discussion offers Medtech and Biopharma professionals a glimpse into industry trends, potentially influencing their strategies for clinical trials and market entry.

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🌎 Expand Your MedTech Trials to New Global Frontiers

Zach Selch is the VP of Global Sales for a high tech medical company and coaches and mentors Global Sales Leaders. Over 30 years he has sold in more than 135 countries, lived in 6 countries, and has driven 4 digit sales growth multiple times while adding hundreds of millions of dollars to the value of companies by building their international footprint.

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🏥 Discover Why Medtech Trials are Moving South

Designing clinical trials for medical devices in Paraguay requires careful planning and regulatory compliance. Here are the key steps to ensure successful trials:

Key Points:

  • Define clear objectives and select appropriate study design
  • Calculate required sample size based on statistical needs
  • Develop detailed protocol and obtain ethics committee approval
  • Submit necessary documentation to DINAVISA for regulatory approval
  • Implement effective participant recruitment strategies

Why It Matters: Following these steps helps medical device companies conduct ethical, compliant trials that advance healthcare innovation in Latin America.

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🩸 One Blood Draw Redefines Clinical Research in Latin America

bioaccess.™ offers comprehensive support for medical device companies entering Latin American markets. This US-based CRO provides end-to-end services from initial research to full commercialization.

Key Points:

  • Specializes in Colombian and Latin American markets
  • Offers regulatory and market access consulting
  • Provides contract research organization services
  • Supports companies from bench to commercialization
  • Focuses on long-term success for foreign medical device firms

Why It Matters: Partnering with bioaccess.™ streamlines market entry and regulatory compliance for medical device companies in Latin America, potentially saving time and resources.

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🌎 Latin America: The new frontier for medtech trials

Latin American clinical research sites execute 13% of global trials, yet face significant challenges in securing their position within the international research landscape. This striking disparity demands immediate attention and strategic solutions. Clinical research excellence demands rigorous qua

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🌎 Latin America: Your Gateway to MedTech Innovation

Thomas Celerier, Marcel Gradidge, and Gautam Narayan are key leaders at the Palo Alto offices. Each brings specialized expertise to different business areas.

Key Points:

  • Thomas Celerier leads Healthcare, MedTech, and Life Sciences
  • Marcel Gradidge directs Business Advisory in Silicon Valley
  • Gautam Narayan heads the Emerge Supply Chain Division
  • All three manage teams and client portfolios
  • Their roles cover diverse sectors in the Palo Alto market

Why It Matters: This leadership team combines deep industry knowledge with local market insights, offering clients comprehensive support across multiple sectors.

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🏥 Latin America Simplifies Medical Device Trials

Jonathan led Livinguard through a pivotal year in 2020. He built teams to drive brand growth, communications, and sales for their antiviral face masks and other new products.

Key Points:

  • Guided company through business inflection point
  • Assembled teams for brand building
  • Developed communication strategies
  • Drove sales for antiviral face masks
  • Launched several new product lines

Why It Matters: Jonathan's leadership positioned Livinguard to meet urgent market demands while expanding their product portfolio.