Hi all, Congratulations! We have completed MDD & AMDD. I found an interesting topic we should discuss or at least we should have idea about it, “Cost and Time of Device Clearance/Approval”. How much does FDA approval cost for new…   Read more»

Hi All, As we have learned, WBS is a tool to define “what” you are doing. Also, there are three reasons to use a WBS in your projects 1- It helps more accurately and specifically define and organize the scope…   Read more»

Negotiations always involve people, so it stands to reason that it is necessary to have a good social skills and strong emotional intelligence when negotiating. When you have emotional intelligence, you are able to define and respond to other people’s…   Read more»

As a PM for a medical device project (for example) it is important to keep projects on budget. As we have learned from Monitoring and Controlling phase lecture, that a positive Schedule Variance number means you are ahead schedule. So,…   Read more»

According to what we have learned from this class,so far, As a PM, Can you share your Ideas about How run Risk Management meeting ? How to start the meeting ? what you need to focus on during the meeting?…   Read more»

Hi All, This week Dr.Simon talked about Risk (Probability that some undesired consequence will occur) and How to manage the risk in a Risk management plan. Let us talk about the definition of Risk/Benefit Ratio ? and How Medical Device…   Read more»

Hi Everyone, SOPs are very important documents to build a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ? For example: I think Procedures is the most important part in…   Read more»

Hi All Last lecture Dr.Simon talked about Risk Management Plan. Let us discuss the Risk Management Plan topic. What’s Risk Management Plan mean and where to start in Risk Management Plan, also what do you know about ISO 14971 standard?…   Read more»

Hi All, In this week lecture Dr.Simon discussed Project Proposal (Initiating), which is the first document in a design control. Let us talk about How to prepare a successful project proposal for designing a Medical Device. What should be included…   Read more»

Hi All, As Dr.Simon mentioned in project management plan you have other things not in the DDP for example: Project Charter Scope Management Plan Communications Plan Quality Plan Risk Management Plan Let us discuss the Quality Plan topic, why quality…   Read more»

Hi All, recently the FDA approved the First Digital Pill in US, Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken, The system works by sending a message…   Read more»

Hi All, As Dr.Simon mentioned about classification in EU is based on risk, Higher risk = higher classification, and Essential Requirements Checklist helps determine classification. In the US, the FDA determines the device class using medical specialty panels, safety and…   Read more»

Hi All, As Dr.Simon mentioned about Tech file: It is a Comprehensive collection of information and documents, Contains Details everything about a medical device, Less complex for MDD Class I and more complex for the others. A technical file is…   Read more»

Hi Everyone, According to the attached article “NDA_Basics: The ABCs of NDAs”: “NDAs are contracts, and usually understandings between two ethical parties. Before you rely entirely on an NDA to protect confidential information, check the references and reputation of people…   Read more»

As Dr.Simon mentioned about Risk management meetings: – Happen throughout process Subsequent meetings to go through process: Evaluate -> Manage -> Measure May need to go through multiple times So, for our project managers(or according to what you have learned…   Read more»

Risk-benefit analysis is the comparison of the risk of a situation to its related benefits. The FDA provided a guidance about the benefit and risk factors to be considered for making decisions concerning product availability, compliance and enforcement. Can you…   Read more»

According to ‘Bryan Campbell article – Process Validation File’: ‘ Process validation is standard for almost any medical component, regardless of classification. While we’ve all heard stories of validations that have run amok, they can result in timely launches, production…   Read more»

According to ‘Bonezone Article – Design Verification – Validation File’, and FDA definition for Verification ‘ Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled’ So, Why do you think Verification is important…   Read more»

The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Here in USA : Design Control – States that when manufacturers or suppliers develop a product subject to design controls, they shall establish and…   Read more»

From this lecture we have learned how to prepare our first DHF file, and as Dr.Simon mentioned about the DHF should contain some basic documents: PDF, DDP, DID – Business plan, market research – Risk Analysis – Research protocols: clinical…   Read more»