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A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

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General Wellness Devices & Wearables: Regulatory Options You Need to Know

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5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

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Regulatory Intelligence (Mis)Management in the Medical Device Industry

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How Software Can Be Leveraged to Streamline Device Development

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Demystifying the FDA's Human Factors Guidance

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What You Need to Know About Medical Electrical Standards Updates

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Advanced Strategies and Tactics for Using the De Novo Pathway

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How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs

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Best Practices for Medical Device Change Management

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How to Create a Risk-based CAPA Process

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Top 10 Most Significant Changes Introduced by the New EU MDR

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How to Prepare for the Medical Device Single Audit Program (MDSAP)

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How QMS Software Can Speed Up Your Product Development & Simplify Compliance

Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to market, and help you pass audits with flying colors.

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How to Prepare for a Successful Design Transfer

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How to Prepare for (and Make the Most of) Your FDA Pre-Submission

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Many Connotations of Risk in Medical Device Development

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What You Need to Know About Life with FDA After Your Device Gains Clearance

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5 Things the Medical Device Industry Should Expect in 2017

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15 Steps to Get Approval to IEC 60601-1

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8 Steps to Implement an EU-MDR Compliance Program

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How to Prepare for the New EU Medical Device Regulations (MDR)

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How to Simplify Your Compliance to the New ISO 13485:2016

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How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

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510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

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Medical Device Project Management Best Practices

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Clinical Evaluation in the EU for Medical Devices

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How To Avoid and Respond to FDA 483's and Warning Letters

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Everything Device Makers Need to Know About Design Controls

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An Overview of ISO 14971 Risk Management

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Understanding the Changes to ISO 13485:2016

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How To Prepare for the Transition to ISO 13485:2016

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How to Manage & Mitigate Risk in New Product Development

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