Regulatory & Compliance Perspectives
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ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs
7/27/2022
Read the FAQs and learn, for example, what the revision of ISO contains and the differences with the previous version.
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Tips For Obtaining Your 510(k) FDA Clearance
7/8/2022
This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the pre-submission process, responding to FDA rejection of your application, and more.
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The Shifting Data Privacy Landscape For Femtech & Beyond
6/29/2022
The lack of an overarching privacy framework for all health data has resulted in a wild west of privacy practices, with some health tech companies prioritizing consumer privacy while other companies do not. The leak of the U.S. Supreme Court’s draft decision in Dobbs v. Jackson Women’s Health Organization has reignited demand for privacy standards. This article examines what this means for femtech and health tech at large.
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The 5 Common Medical Device Startup Challenges (& How To Overcome Them)
6/20/2022
The medical device market is a land of both opportunity and risk for enthusiastic, innovative developers. Understanding the most common challenges device developers face, and how to successfully navigate them, can provide the competitive edge an entrepreneur needs to succeed in this environment.
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2 Years After Germany’s Regulation For Digital Health Apps, What Can We Learn?
6/10/2022
At the end of 2019, the Digital Healthcare Act introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany. Many consider the act a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Two years and 28 approved digital health apps later, what can we learn?
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The Voluntary Improvement Program: FDA Seeks Public Comment On Draft Guidance
6/6/2022
The FDA seeks comments on its proposed guidance describing its policy regarding FDA's participation in the Voluntary Improvement Program. The program is facilitated by the Medical Device Innovation Consortium. Comments are due by July 5, 2022.
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MDSAP Audit Approach Updated From Rev. 6 To 7
6/2/2022
On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.
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IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy
6/1/2022
European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.
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FDA Releases Guidance On Cybersecurity In Medical Devices
5/31/2022
The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
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How Does Pursuing ESG Measures Give My Medtech A Competitive Edge?
5/27/2022
Amid continuing focus on environmental, social, and governance (ESG) priorities among investors across every industry, medtech companies need to begin revisiting business models and developing new sustainability strategies for competitive edge as well as regulatory compliance.