Operon Strategist

Medical Devices Assembly

Ensuring Regulatory Compliance in Medical Devices Assembly for India’s Market

Medical Devices Assembly – An Overview The global medical device manufacturing industry is experiencing rapid growth, expected to expand by 11.6% (as per Masterson). This growth surge presents an opportunity for professionals in manufacturing, healthcare, and engineering to explore or advance their careers.   Wish to Diversify in Medical Device Industry? Enter manufacturing by the assembly of […]

Ensuring Regulatory Compliance in Medical Devices Assembly for India’s Market Read More »

Medical Device Regulatory Requirements in Lebanon

A Quick Guide to the Medical Device Regulatory Requirements in Lebanon

An Overview to Medical Device Regulatory Requirements in Lebanon Lebanon is a growing market for medical devices in the Middle East, known for its healthcare infrastructure and demand for quality health products. While the country heavily depends on imported medical devices, it has established a regulatory framework to ensure safety, efficacy, and compliance. This guide

A Quick Guide to the Medical Device Regulatory Requirements in Lebanon Read More »

CE Mark vs FDA Approval

CE Mark vs FDA Approval For Medical Devices

Why Understanding CE Mark vs FDA Approval Matters For medical device manufacturers aiming for global expansion, choosing between CE Mark vs FDA Approval is a crucial decision. Both certifications ensure safety, quality, and compliance, but they follow distinct regulatory systems, timelines, and documentation processes. Understanding their differences helps you plan your market entry effectively and

CE Mark vs FDA Approval For Medical Devices Read More »

FDA Has Now Regulated Laboratory Developed Tests as Medical Devices.

FDA Has Now Regulated Laboratory Developed Tests as Medical Devices

FDA’s Move to Regulate Laboratory Developed Tests as Medical Devices In a significant development, the US Food and Drug Administration (FDA) has introduced a groundbreaking rule change that will impact the regulation of Laboratory Developed Tests (LDTs) and In Vitro Diagnostic Products (IVDs). Under these new regulations, LDTs are set to be classified and regulated

FDA Has Now Regulated Laboratory Developed Tests as Medical Devices Read More »

Best Practices for Selecting Predicate Devices

FDA Published Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

Draft on Best Practices for Selecting Predicate Devices for FDA 510(k) Notification On September 6, 2023, the US Food and Drug Administration (FDA) took a significant step towards enhancing and modernizing the 510(k) Program, aimed at providing greater predictability, consistency, and transparency in the 510(k) premarket review process. Specifically, the FDA released a set of

FDA Published Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications Read More »

Medical Device Registration in Latam Countries

Medical Device Registration in LATAM Countries

Medical Device Registration in LATAM: An Overview Latin America’s growing healthcare sector has led to a rising demand for medical devices, creating valuable opportunities for global manufacturers. However, entering LATAM markets can be challenging due to differing regulatory requirements across countries. This blog highlights how Operon Strategist, a leading medical device regulatory consultant, supports manufacturers

Medical Device Registration in LATAM Countries Read More »

Education Scheme for the Medical Device Sector

The Government Has Approved an Education Scheme for the Medical Device Sector

Education Scheme for the Medical Device Sector The government has given the green light to a ₹480 crore initiative aimed at nurturing a skilled workforce to propel the growth of the medical devices industry. This three-year scheme is set to offer financial support to government institutions, enabling them to offer a range of courses related

The Government Has Approved an Education Scheme for the Medical Device Sector Read More »

Scroll to Top