Medical Device Courses | Abhishek Trivedi | Activity https://medicaldevicecourses.com/members/abhitrivedi1211/activity/ Activity feed for Abhishek Trivedi. Sat, 25 Apr 2026 01:28:35 -0400 https://buddypress.org/?v= en-US 30 hourly 2 364fb572ed2018f46c8874506e6824dd Abhishek Trivedi replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11415/ Wed, 15 May 2019 16:44:46 -0400 To give yourself the ‘ultimate protection’ from having your idea stolen, it is a good idea to have a three step process. Step 1. Apply for patent protection If your invention can be protected by a patent, applying for this…   Read more»

]]> 4d28d5b74c5cff528c32e384b73d51e1 Abhishek Trivedi replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11412/ Wed, 15 May 2019 16:44:45 -0400 As someone who works in the medical device industry, I can say that this course did a great job of covering most of the different aspects of the field. We learned a wide range of topics which give an excellent…   Read more»

]]> 0330e556c750f574e7a2cd36fcaaeb86 Abhishek Trivedi replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11401/ Wed, 15 May 2019 16:44:36 -0400 I actually found a recent example of kickback allegations. The company is called Tenet Healthcare- a healthcare services company headquartered in Texas. The prenatal clinics allegedly referred undocumented Hispanic women to Tenet hospitals, which charged Medicaid for deliveries. The hospitals…   Read more»

]]> bb63d80dc715c75f5418ec228775db2b Abhishek Trivedi replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11108/ Wed, 15 May 2019 16:39:58 -0400 My company uses FMEA (Failure Modes Effects Analysis) for risk assessment. An FMEA is a step by step approach to identify all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes are…   Read more»

]]> 3b35f42411120bcaf6d3889181a56e64 Abhishek Trivedi replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11048/ Wed, 15 May 2019 16:39:24 -0400 I agree that is is important to analyze external factors! Once example I know is that IQ’s (part of validation) are needed even if the product is moved one foot on the product assembly line because you have to consider…   Read more»

]]> 5ee9736004f28874cab22e7473dd9dd5 Abhishek Trivedi replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11045/ Wed, 15 May 2019 16:39:22 -0400 Hi Roberto, In addition to the points some people mentioned above, I believe there are some additional benefits to keeping meeting minutes: 1. They offer legal protection. 2. They provide structure. 3. They drive action. 4. They act as a…   Read more»

]]> bca02ee8b50d7462c62adad9c419ac67 Abhishek Trivedi replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/11042/ Wed, 15 May 2019 16:39:20 -0400 In my R and D work experience, I worked a lot with new product development and just as our senior design projects, customer needs/design requirements and test plans are huge deliverables. Once the customer told us their needs (in my…   Read more»

]]> 2644d1039951194c8915bf11ae5744e7 Abhishek Trivedi replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10897/ Wed, 15 May 2019 16:37:41 -0400 I believe it is important to directly quote the FDA about design inputs (ISO 13485:2003) Inputs relating to product requirements shall be determined and records maintained. These inputs shall include: a) functional, performance, and safety requirements, according to the intended…   Read more»

]]> 8d58133f20468bdd04a6fc7d54ee4083 Abhishek Trivedi replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10894/ Wed, 15 May 2019 16:37:39 -0400 I think the following is a great way to think of verification vs validation: Validation: Are we building the right system? Verification: Are we building the system right? In other words, validation is concerned with checking that the system will…   Read more»

]]> ada3dcdb598d7e5b94ff7e6d068774ae Abhishek Trivedi replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10890/ Wed, 15 May 2019 16:37:36 -0400 Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently…   Read more»

]]> af711b23252f41423b34a98fba4c67a2 Abhishek Trivedi posted a new topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/10404/ Wed, 15 May 2019 16:33:17 -0400 What factors contribute to determining values for risk index numbers.

Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’.

]]> 5482eda4821694e68a7c052c9474d088 Abhishek Trivedi posted a new topic "Sample Size Based on Risk Analysis" - https://medicaldevicecourses.com/activity/p/10403/ Wed, 15 May 2019 16:33:17 -0400 How would a company use risk index numbers/values to determine sample size for protocols (e.g. validation)? If you are in industry- perhaps you can give examples of what occurs in your companies? For example in my company, if there is…   Read more»

]]> 6bd940053b4e9f2dfb5d4ac7d475279d Abhishek Trivedi replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/916/ Mon, 05 Dec 2016 02:31:10 -0500 To give yourself the ‘ultimate protection’ from having your idea stolen, it is a good idea to have a three step process.

Step 1. Apply for patent protection

If your invention can be protected by a patent, applying for this protection should be your first step before discussing it with anyone except a patent attorney.

Step 2. Prepare a…[Read more]

]]> 0 cf88b5d17644b67e7cf5bfbf2e18cbae Abhishek Trivedi replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/913/ Mon, 05 Dec 2016 02:12:41 -0500 As someone who works in the medical device industry, I can say that this course did a great job of covering most of the different aspects of the field. We learned a wide range of topics which give an excellent background on how these large medical device companies work. In addition, this project is giving us real world experience on developing a…[Read more]

]]> 0 3fbe9aea9cac9934f148f8bd8a83fd5b Abhishek Trivedi replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/901/ Mon, 05 Dec 2016 00:31:41 -0500 I actually found a recent example of kickback allegations. The company is called Tenet Healthcare- a healthcare services company headquartered in Texas. The prenatal clinics allegedly referred undocumented Hispanic women to Tenet hospitals, which charged Medicaid for deliveries. The hospitals used contracts for translation and other services to…[Read more]

]]> 0 9b11d9a85cc457251a1810c6228aee12 Abhishek Trivedi started the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/537/ Fri, 18 Nov 2016 16:33:42 -0500 What factors contribute to determining values for risk index numbers.

Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’.

]]> 0 196aa8e58aa6eb4bc5e804c6a5d6b104 Abhishek Trivedi started the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/536/ Fri, 18 Nov 2016 16:27:46 -0500 How would a company use risk index numbers/values to determine sample size for protocols (e.g. validation)? If you are in industry- perhaps you can give examples of what occurs in your companies?

For example in my company, if there is a high risk index number, the sample size needed for testing would have to be greater. For example, my company…[Read more]

]]> 0 7fe065240e9697bce923a2d0f1b0454b Abhishek Trivedi replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/535/ Fri, 18 Nov 2016 15:58:16 -0500 My company uses FMEA (Failure Modes Effects Analysis) for risk assessment. An FMEA is a step by step approach to identify all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes are the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that…[Read more]

]]> 0 3dab53866e0bfdc248246d558c823f4a Abhishek Trivedi replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/534/ Fri, 18 Nov 2016 15:58:16 -0500 My company uses FEMA (Failure Modes Effects Analysis) for risk assessment. An FMEA is a step by step approach to identify all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes are the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that…[Read more]

]]> 0 2cecd064eeec67356a7888f63206a165 Abhishek Trivedi replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/451/ Mon, 14 Nov 2016 04:48:27 -0500 I agree that is is important to analyze external factors! Once example I know is that IQ’s (part of validation) are needed even if the product is moved one foot on the product assembly line because you have to consider things like “Is there any outlet nearby?”, “Does the new outlet supply enough power?”, etc.

]]> 0 7b451f6c7a6ee5c88da5e5da4fb5c810 Abhishek Trivedi replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/448/ Mon, 14 Nov 2016 04:42:46 -0500 Hi Roberto,

In addition to the points some people mentioned above, I believe there are some additional benefits to keeping meeting minutes:

1. They offer legal protection.
2. They provide structure.
3. They drive action.
4. They act as a measuring stick.
5. They state ownership.

Source: http://www.allbusiness.com

]]> 0 9aba5fd431b957c7bd3b24e3dabfd831 Abhishek Trivedi replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/445/ Mon, 14 Nov 2016 04:38:09 -0500 In my R and D work experience, I worked a lot with new product development and just as our senior design projects, customer needs/design requirements and test plans are huge deliverables. Once the customer told us their needs (in my case a perfusionist), we were able to write the design requirements for a particular heart lung machine. We then had…[Read more]

]]> 0 6935f8c89d46688026accc0e1460d39e Abhishek Trivedi replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/248/ Mon, 07 Nov 2016 02:27:11 -0500 I believe it is important to directly quote the FDA about design inputs (ISO 13485:2003)

Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where…[Read more]

]]> 0 d8a8ce88aa90106da5c825d89079d983 Abhishek Trivedi replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/245/ Mon, 07 Nov 2016 02:17:38 -0500 I think the following is a great way to think of verification vs validation:

Validation: Are we building the right system?
Verification: Are we building the system right?

In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is w…[Read more]

]]> 0 dc702997c8707654b6e0514f413e3965 Abhishek Trivedi replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/244/ Mon, 07 Nov 2016 02:17:38 -0500 I think the following is a great way to think verification vs validation:

Validation: Are we building the right system?
Verification: Are we building the system right?

In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is w…[Read more]

]]> 0 2198f61c4395b065651d05d3ac19cf5e Abhishek Trivedi replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/239/ Mon, 07 Nov 2016 02:08:07 -0500 Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product’s intended use. Design inputs, outputs, review, change…[Read more]

]]> 0 657bfa1c5ba165340b37c41cba0beb0f Abhishek Trivedi became a registered member https://medicaldevicecourses.com/activity/p/227/ Mon, 07 Nov 2016 01:20:01 -0500 0