Operon Strategist – Page 28 – Operon Strategist

Regulatory Budgeting for Drug Device Combination Products: EU MDR

Introduction to Regulatory Budgeting for Drug Device Combination Products : The research, development and commercialization of drug-device combination products is gearing up in the pharmaceutical industry. These products offer unique therapeutic advantages and improved patient outcomes, but they also come with complex regulatory requirements and financial considerations for certain country approvals. In this blog, we […]

Regulatory Budgeting for Drug Device Combination Products: EU MDR Read More »

Understanding US FDA Renewal for Medical Device

Yearly FDA Renewal for Medical Device Operon Strategist guides clients through the complex and ever-evolving regulatory landscape of the healthcare industry. One of the important aspects of this process is FDA renewals for medical devices. In this blog, we’ll explore the intricacies of FDA renewals, why they matter, and how to successfully navigate the renewal

Understanding US FDA Renewal for Medical Device Read More »

Driving Innovation in the Medical Devices Sector of India: What It Requires

The Beginning of the Transformation of the Industry In India, fostering collaboration among stakeholders is seen as the linchpin for advancing the development of high-quality medical devices that can effectively address patient needs while ensuring sustainability. A recent report jointly published by KPMG in India and the Asia Pacific Medical Technology Association highlights the existing

Driving Innovation in the Medical Devices Sector of India: What It Requires Read More »

A Guide to Medical Device Sterilization Methods

When it comes to medical devices, safety and hygiene are of most importance. Ensuring that medical devices are free from harmful microorganisms and safe for patient use is crucial. This is where sterilization comes into play. In this comprehensive guide, Operon Strategist will shedding light on the various methods used to sterilize medical devices and

A Guide to Medical Device Sterilization Methods Read More »

A Guide to FDA Communication for Medical Devices

In the ever-evolving world of medical devices, navigating the intricate regulatory landscape is essential for bringing your innovation to market. The United States Food and Drug Administration (FDA) plays a pivotal role in this journey. Effective FDA communication is key to ensuring that your medical device meets all regulatory requirements and reaches the hands of

A Guide to FDA Communication for Medical Devices Read More »

5 Essential Tips for Medical Device Manufacturing Site Selection

An Overview: Medical Device Manufacturing Site Selection Choosing the right location for your medical device manufacturing is a critical decision that can significantly impact the success of your business. Factors such as access to a skilled workforce, regulatory environment, and transportation networks play a crucial role in determining the ideal site for your medical device

5 Essential Tips for Medical Device Manufacturing Site Selection Read More »

India Enhances Patient Safety with New IVD Device Classification

In a significant development aimed at strengthening medical device regulation and patient safety, the Central Drugs Standard Control Organization (CDSCO) of India has recently classified in-vitro diagnostic (IVD) medical devices. This classification, conducted under the provisions of the Medical Devices Rules (MDR) – 2017, represents a proactive effort to enhance the safety, quality, and performance

India Enhances Patient Safety with New IVD Device Classification Read More »

DoP’s Guidelines for the Medical Devices Sector: Building a Skilled Workforce

DoP’s Guidelines for Medical Devices Sector The Department of Pharmaceuticals (DoP) has unveiled operational guidelines for its Human Resource Development scheme within the Medical Devices Sector. The initiative is set to train approximately 5,400 students over a span of three years, aiming to bridge the divide between the industry and academia. Its overarching goals include

DoP’s Guidelines for the Medical Devices Sector: Building a Skilled Workforce Read More »

A Comprehensive Guide to Stent Manufacturing

Introduction to Stent Manufacturing: In the vast landscape of healthcare, stents stand as unsung heroes, silently working their magic in the realm of cardiovascular and vascular treatments. These unassuming devices have not only saved countless lives but have also redefined medical possibilities. In this comprehensive guide, we will embark on a fascinating journey into the

A Comprehensive Guide to Stent Manufacturing Read More »

SaMD Classification and Submission as per USFDA

Overview – SaMD Classification SaMD refers to software applications designed to perform medical functions, transforming the way we diagnose, treat, and monitor patients. To ensure the safety and effectiveness of these digital tools, regulatory bodies like the U.S. Food and Drug Administration (FDA) have established a framework for their classification and submission. Operon Strategist is

SaMD Classification and Submission as per USFDA Read More »