Post Market Clinical Follow-up of medical devices is an important part of Post Market Surveillance. It is the process of monitoring devices in the real world environment.
Post Market Clinical Follow-up – Medical Devices Read More »
Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.
Post Market Surveillance – Medical Devices Read More »
Medical device clinical evaluation is an essential part of regulatory compliance. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose.
Medical Device Clinical Evaluation Read More »
ISO 14971 is the global standard for managing risks in medical devices, guiding manufacturers through identifying, evaluating, and mitigating risks throughout the product lifecycle.
ISO 14971 and the Risk Management of Medical Devices Read More »
The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.
Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.
EU Authorised Representative Read More »
PPE Regulations are in place to ensure the safety, quality, and efficacy of products used to protect the body from hazards. Regulations ensure that personal protective equipment is fit for purpose and conforms to standards.
Personal Protective Equipment (PPE) Regulations Read More »
Cosmetics Regulations are in place to ensure the safety, quality, and efficacy of products used on the skin, hair, and body. Regulations prevent the inclusion of harmful ingredients, protect consumers from potential health risks, and ensure accurate labeling and claims.
Cosmetics Regulations Read More »
In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.
The Biological Evaluation of Medical Devices Read More »
The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.
CE Marking Medical Devices Read More »
When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in.
Is My Product a Medical Device? Read More »
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