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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Digital health technologies have become a focus for investors in the healthcare industry in China. The NMPA has set various laws and policies regulating digital health technologies. The NMPA considers digital devices such as healthcare apps, wearables, and Software as a Medical Device (SaMD) as medical devices under the Medical Device Regulation (Order #739).
Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practitioners in decision-making for better patient care.
The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022.
Software and Artificial Intelligence (AI) play an important role in the medical device sector, with a fast-developing and wide set of applications in the health care system. Most of the applications will be regulated as medical devices and can range from screening to diagnosis to treatment and management of chronic conditions.
Over the past few decades, the use of software has drastically advanced and brought about rapid changes in the medical device industry. The increasing importance of software in medical devices and the patient’s experience is crucial for further developments. However, SaMD has challenges for both regulators and the medical device industries alongside the new opportunities.
With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions.
The application of software technologies in varied healthcare management, including diagnosis or treatment of a disease condition, is accelerating at an unprecedented rate. The global medical device Authorities are revamping their regulations and guidelines to address these booming device technologies.
It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition.
In recent times, the use of AI/ML (Artificial Intelligence/Machine Learning) has taken a huge technological sweep in the medical devices and healthcare industries because of their ability to diagnose, manage and treat a wide variety of medical conditions and to enhance the patient care.
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