Guest Columns

  1. Understanding Clinical Evaluation Reports Under The EU MDR

    Despite the CER being a critical compliance element for medtechs doing business in the EU, there continues to be significant lack of clarity regarding key requirements and best practices for creating these reports.

  2. Global Impact: China’s Regulations On The Supervision And Administration Of Medical Devices

    As China’s National Medical Products Administration nears finalization of its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device companies should understand the impact these changes will have on the global medical device market.

  3. Apple Watch Approval Marks Shift In Device Development And Approvals

    Getting to this point has been a multi-year progression of technological development and regulatory evolution by both the market and government.

  4. Data (Integrity) Pirates: Preventing And Detecting Malicious Intent

    During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?” 

  5. EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes

    Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.

  6. Startups Illustrating The Future Of Global Medtech

    Globally aware CEOs are looking beyond rich country patients for long-term growth. This article highlights a pair of startups attempting to bring innovation large, under-served populations, and analyzes the effectiveness of their approach.

  7. When To Use A Fishbone Diagram And Why You Should Do It More Often

    This article provides an in-depth and comprehensive explation one of the most broadly applicable and durable root cause analysis tools to investigate the quality of your manufacturing processes: the fishbone diagram.

  8. Asian Hip/Knee Implant Market Primed For Drastic Procedure Volume Increases

    The hip and knee replacement markets in India and China currently are underserved, and present tremendous opportunities for large joint device manufacturers.

  9. Training And Memory Decay In Simulated-Use Testing

    One topic that often generates confusion — and sometimes heated debate — is whether study participants should be trained on a product’s use prior to testing. Trained participants may be more likely to use the product as intended during testing but, as testing is intended to simulate real-life product use, training may not always be appropriate.

  10. Auditor Evaluations: A GMP Auditing Best Practice

    Given the importance of auditor performance, do managers responsible for audit programs solicit and provide feedback on auditors? Very rarely.