Arya Panda

Establishing a strong quality management system is vital when creating a medical device (QMS). Adhering to the pertinent national and international regulatory regulations is crucial while developing your QMS. The two most important ISO standards in terms of quality management are ISO 13485 and ISO 9001. Although ISO 9001 served as the foundation for ISO […]

Many believe that a QMS Certification is a must for a medical device company and that having one will ensure that you are in compliance. It is a legal requirement that the FDA (Food and Drug Administration) or the ISO auditors cite as being fundamental that a QMS certification be held. It ensures ISO and […]

The Indian government established a savings program in 1952 for the social security and wellbeing of both organized and unorganized workers. Employees’ Provident Funds (EPF) was the name given to it. The Employees’ Provident Funds and Miscellaneous Provisions Act governs this savings plan. The Employees’ Provident Fund Organization (EPFO) is in charge of the Scheme. […]

A medical device is considered sterile if it is free of live microorganisms. When it’s necessary to supply a sterile medical device, international standards mandate that accidental microbiological contamination of a medical device prior to sterilization be minimized. These standards define the requirements for validation and routine control of sterilization processes. Nevertheless, even after sterilization, […]

A Regulatory Compliance Strategy for Medical Devices is a routinely published official report that modifies the business strategy and regulatory actions to introduce a new or altered medical device to the market. It acknowledges the important regulatory components that must be addressed and gives the task’s overall definition. Medical devices manufacturers can more successfully plan the […]

Medical device companies have embraced digitization today, but manufacturers still face many challenges, including implementing a QMS and complying with regulatory requirements. Vital sign monitors are effective for assessing a patient’s health since they deliver precise data quickly. The information it provides offers insightful information about a patient’s actual condition. If a patient is not […]

It might be wise to start creating disposable syringes. For launching a disposable syringe manufacturing business, the requirements are virtually identical to those for starting a pharmaceutical manufacturing business. Along with a NOC from the pollution department, the drug control agency must also give its clearance before you may manufacture syringes. While making disposable syringes, […]

The dental implant is also referred to as an endosseous implant or fixture. It is a precise component that connects to the jawbone or skull to support a dental prosthesis, such as a crown, extension, or denture, or facial prosthesis, or to function as an orthodontic anchor. Modern dental implants are based on a biological […]

The India approval process for medical devices has attracted a lot of attention. In recent years, the Indian medical regulatory system has gotten more intricate. In the past, there was no requirement for medical devices to receive any approval; this is no longer the case. There are around 30 devices “families” in India that specify […]

Medical device design consulting that effectively addresses healthcare regulatory compliances, and solution specifications, and delivers functionalities that meet the needs of end users. A manufacturer must be compliant with Indian regulations and legislation in order to legally import, market, or manufacture medical devices and/or IVDs in India.  Manufacturers of medical devices & in vitro diagnostic […]

PRRC is an acronym that stands for the person responsible for regulatory compliance. It is one of the new requirements of the European Union’s Medical Device Regulation (MDR) & In-Vitro Diagnostic Medical Device Regulation (IVDMDR) (IVDR). Its goal is to ensure that businesses have access to a qualified regulatory expert. Article 15 of the EU […]

A working group was established by the International Medical Device Regulators Forum (IMDRF) to create a set of standards for certification bodies (auditing organizations) that conduct regulatory audits of medical device manufacturer’s quality management systems. The rules, known as the Medical Device Single Audit Program (MDSAP), are applicable to regulatory agencies as well as independent […]

One component, the medical device packaging, frequently gets overlooked while developing or thinking through the production process for a medical device. The packing may be lost in the sea of other concerns that must be attended to. Yet, using the appropriate packaging can cut costs, possibly improve sterilizing procedures, and facilitate manufacturing. Early packaging consideration […]

Prior to a medical device’s release on the market, usability testing and validation are essential duties. Usability is a crucial part of overall risk management and safety since it considers how the user interacts with your product. Making sure you’re creating a secure and useful product for the consumer is the ultimate goal of early […]