A CE (Conformitè Europenne) Mark is mandatory for medical devices manufactured, designed, marketed, and supplied within the European Economic Area (EEA) & European Union (EU). The CE Mark is a representation of the manufacturer’s declaration that the product complies with the EU’s applicable directives/regulations. Compared to the MDD & IVDD, the current MDR 2017/745 &…
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Quality in a service or a product is not what you put into it; it’s what the end user gets out of it. In healthcare, the term “quality” has a lot of importance as it helps to achieve greater consistency in activities that are involved in the development of products and services. It increases efficiency…
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Diagnostic laboratories in today’s world face a slew of issues; from managing complicated test panels to handling ever-increasing sample quantities. In order to overcome such problems, busy laboratories discover new methods to expand. They make themselves flexible, necessary enough, to keep up with the proliferation of pathogens. Knowing the regulatory environment is crucial for the…
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The Federal Food Drug and Cosmetic (FD&C) Act established three regulatory classes for medical devices – Class I, Class II, and Class III, in order to ensure that the devices are safe and effective for public health. To permit only the safest and most effective medical devices into the market, the FDA has three levels…
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One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that demonstrates the safety, performance, and efficacy of your device. What is a CER? CER is a report of the assessment and analysis of a medical device’s clinical data which is typically collected to…
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For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on their intended purpose should always be the first step. As per the EU regulations, the classification is based on the risks involved in the device. It is very important to classify your device…
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Misbranding is a serious issue in the healthcare industry. For all the claims, indications for use, and other labeling details accompanying the product there must be some supporting data on file to avoid misbranding of your device. Misbranding can result in inadvertent misuse and potential adverse events. Example of misbranding An example of this is…
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Stop worrying about enforcing a safety culture! A safety culture can be built by constantly making people aware of reporting regulations and requirements based on the countries in which you are selling your medical devices. If your medical device is currently sold in Australia the prompt Incident Reporting of Medical Devices by the Australian TGA…
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What do the applicants of 510(k) or other regulatory applications or companies looking to register or import need to pay? The FDA has amended the user fee for the fiscal year 2022, and there is about a 2.5% rise in the fees for various medical device manufacturers, importers and distributors on the regulatory applications where…
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As we all know that symbols play a very important part in medical device labeling, hence it is critical to know when the relevant standard undergoes changes. If you are a medical device manufacturer or Innovator and want to know more about the latest version of the ISO 15223-1:2021, then, this article is for you!…
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Background
Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 10 years of overall experience where 6 years were spent by Amit in core medical device troubleshooting and compliance, Amit is able to adopt a very pragmatic approach when helping Clients with testing and compliance issues. Amit is a dedicated professional with attention to details. He has helped successfully navigate many Clients through various stages of regulatory approvals.
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Background
An executive with 15+ years of global, medical and research experience. Demonstrated successes through NIH grant acquisition, board certification, launch campaigns, and executive leadership. Proven industry experience across multiple therapeutic areas (Oncology, Psychiatry, Neurology, etc): Medical Affairs (MA) operations – Medical Education & Writing – Clinical research (P1-4) – Regulatory Affairs – Strategy – leadership –organizational development. Medical Affairs management experience has continually been enhanced from developing new departments to assisting well-established ones for companies with annual revenues of $10M to multi-billion. A natural leader that leverages innate and trained communication skills to effectively coach staff, build talent, develop robust teams, minimize conflict, and drive projects to successful completion with a sense of purpose and attention to detail.
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Background
Mr. Vivek Goyal is an IIT Electrical Engineering and Stanford GSB alumni. He is highly passionate about creating successful businesses, helping companies optimally position themselves and their value proposition, and solving various complex technological problems through advanced software methodologies.
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Background
Ms. Parul is a Biomedical Engineer by profession with more than 15 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.
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