We’re truly glad for our website and work hard to stay up with the latest content and the medical device blog. We love hearing from existing and potential customers and other visitors about what they find especially useful because our site offers not just service information but medical device blogs like this, regulatory information on medical devices, procedures and medical device related news update. With the new year underway, we thought we’d take a look back at our 11 medical device blogs of 2018.
Medical Device Registration in India | CDSCO:
With the rising opportunities in India comes increasing regulations that companies must face and overcome. With the assistance of a highly experienced third-party regulatory compliance consultant such as Operon Strategist, the registration process is much less complex. We can help you prepare and submit the required documents and materials to the relevant regulatory agencies in India. Read More
Better Insights for ISO 13485 2016 Validation Requirements
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. In order to demonstrate that the process has produced an output that meets the specified requirements. The solution to this problem is process validation. This medical device blog provides details on how Operon Strategist helps in documentation & examining for ISO 13485 certification. Read More
FDA Inspections vs ISO Audits: FDA 21 CFR Part 820 and ISO 13485
In our previous medical device blog posts, we provided a high-level overview of medical device quality management systems, followed by a discussion on key components of a QMS that meets US FDA and EU requirements. In this medical device blog, you will take a look at key sections of ISO 13485:2016 and the FDA Quality System Regulations, and provide the comparison of the Quality Management System (QMS) requirements between the US FDA 21 CFR Part 820 regulation and the international ISO 13485 standard. Read More
What is CAPA and Why You Need It?
To achieve greater quality in manufacturing you need to understand the essential elements of quality management, continuous improvement, and process discipline .i.e. CAPA (Corrective action and preventive action) which is the requirement of USFDA. Operon Strategist has been helping medical device professionals with quality and regulatory compliance for many years. Our team can work with you to assess the effectiveness of your CAPA program and train your team on optimizing the program’s effectiveness. Read More
ISO 14644 Standard – Why is it necessary for your Cleanroom?
The International Organization for Standardization (ISO) published the long-awaited revisions to its standards for classification and monitoring of air cleanliness in cleanrooms on Dec. 15, 2015. ISO14644 is the international standard used to design, construct, validate and operate a cleanroom. This blog will help you with the general questions with the solution to understanding the importance of a Cleanroom in the medical industry. Read More
4 Common Misconceptions About Medical Device Labeling
When you first start designing and developing a new medical device, you spend a lot of time learning what design controls are and how to apply them. You spend a lot of time learning around risk and how to mitigate it. And you assume that when it comes time to create the labeling for the device, it’s going to be easy. This blog will help you with the misconceptions about medical device labeling which will be cleared to you by this blog. Read More
FDA medical device approval process step-by-step guide
FDA approval means that the FDA has formally approved your product. This is important to establish that your device is safe and effective. But to get FDA approval, you’ll need to prove compliance. FDA compliance means following product safety regulations set by the FDA. You’ll need to prove compliance in order to get your device out to market. And we Operon Strategist makes it easy to manage and track requirements, tests, and issues all in one spot that helps you prove compliance faster, so you can get your device to market on time. Read More
The Ultimate Guide to Design Control for Medical Device Companies
Design and development of a medical device is the most crucial phase for its success. During the design and development stage of the medical device design process, we assist various medical device manufacturing industries to ensure that appropriate steps are taken to meet regulatory compliances of the medical device design and development. Read More
How to Export Medical Devices in India
The regulatory licenses issued for import, manufacture or sale of medical devices have been made never-ending in nature to eliminate unnecessary and time-consuming paper-work, in an offer to build simplicity of working together in India. Read More
Effective phases of Medical Device Development
Do you have a medical device to launch? Medical devices are not easy to launch and are masked with layers of regulations. Here in this medical device blog, there are the 5 stages of medical device development that are widely popular as well as complex in coming years. Read More
Ultimate Guide On Medical Device Registration in 9 Different Countries
This medical device blog is for every manufacturer who wants the medical device registration in different countries all around the globe. Operon Strategist has all experience and expertise in handling the project globally. Projects deliverables and timelines are tracked/handled through meticulous planning by our team. Read More