Medical Device Courses | Juan Javier | Activity https://medicaldevicecourses.com/members/jej7/activity/ Activity feed for Juan Javier. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5ea0cc730c4b6edc729ffd6ea221544f Juan Javier replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11411/ Wed, 15 May 2019 16:44:44 -0400 There is a huge difference between an NDA and a patent. The patent is a federal document utilized to protect and enforce the exclusivity of an idea. An NDA is a contract between two people or a person and an…   Read more»

]]> ef5d29b664b6af2948b8da839451f0ed Juan Javier replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11409/ Wed, 15 May 2019 16:44:44 -0400 I don’t think you have to go too deep into kickback allegations to find some really high profile cases. Take this case with Senator Robert Menendez and his Floridian eye doctor associate. http://www.businessinsider.com/bob-menendez-defense-fund-took-money-from-developer-jailed-for-kickbacks-2015-4 Where Senator Menendez was indicted on 14…   Read…[Read more]

]]> 0eda0810ddb240f67c0ad7f0e050add0 Juan Javier replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11406/ Wed, 15 May 2019 16:44:42 -0400 There is an old adage that a wise engineer once told me; Always, always get everything in writing. Getting things in writing would make everyone’s life easier… But only if the person who prepared that document is ready to devote…   Read more»

]]> ce209697d118fdb1c9b1e2a4957818fa Juan Javier replied to the topic "Organizational structure and Culture both leading to project success?" - https://medicaldevicecourses.com/activity/p/11299/ Wed, 15 May 2019 16:43:43 -0400 I also agree with this. The way managers and directors express their direction promotes the team building within the department. I have experienced both sides of the coin and like you I do prefer the welcoming work culture. Even though…   Read more»

]]> 3b00b0ddf0d4cf815bb3b644cc81d776 Juan Javier replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11298/ Wed, 15 May 2019 16:43:43 -0400 I believe that it is much better to work with someone who is knowledgeable and would occasionally give you a tough time than with people who you are highly comfortable with. This way, any potential hurdles/conflicts are handled professionally making…   Read more»

]]> e5fbb7ae8cb41989d891b5371e5612a3 Juan Javier replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11295/ Wed, 15 May 2019 16:43:41 -0400 I highly agree with this sentiment. Corporate culture can change in the blink of an eye. I too share the same experience where shuffling management has resulted in a drastic change of perceived job security and camaraderie. However, the amount…   Read more»

]]> b5c672eeba2cef4d5601e6e8ce393e56 Juan Javier replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11174/ Wed, 15 May 2019 16:40:32 -0400 Usually the quality management system establishes the guidelines to periodically perform a risk assessment. This risk assessment is performed by people who are qualified to perform such activities; an engineer familiar with the device, a quality representative that performs CAPAs…   Read more»

]]> 79b6875bfc385887f3ff1ad1ff76d0d1 Juan Javier replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11171/ Wed, 15 May 2019 16:40:30 -0400 This is a great discussion topic! I believe many of the failures in risk assessment can come from a lack of resources within the company. By resources I mean information and or the personnel required to adequately provide an honest…   Read more»

]]> 78225cb916a3c0f5edf168efe0b8f237 Juan Javier replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11169/ Wed, 15 May 2019 16:40:29 -0400 As already discussed by others, the best ways are a quality system supported DFMEA matrix, collecting information from various sources such as the complaints department and the past quarter’s CAPAs and NCRs, SWOT analysis and others. I believe the best…   Read more»

]]> bef69eb7806da605c57a7febe7a6d819 Juan Javier replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/11050/ Wed, 15 May 2019 16:39:26 -0400 I believe that Gantt charts are great to keep you in focus with what your deliverables, milestones and project scope should be. In my industry experience, I’ve used Gantt charts to address CAPAs and NCRs. The CAPAs would require a…   Read more»

]]> 88c2356e1dac0530018fd23dab64e2ab Juan Javier replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/11047/ Wed, 15 May 2019 16:39:23 -0400 Roberto this is an excellent topic of discussion and as you will find in the field, often a topic of contention. The FDA provides guidelines on how tests should be executed. Take a look at the recent changes to the…   Read more»

]]> 89db36978beaf2f9495013806f687d2e Juan Javier replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11043/ Wed, 15 May 2019 16:39:20 -0400 Even though the lecture cited examples, I would sleep easier knowing validations were done to mitigate risk. Even if there were no changes affecting the human factors of the device, you still need to check the product. What if there…   Read more»

]]> d55c4cb70f4073ed2b1c7fd1bc89f198 Juan Javier replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10903/ Wed, 15 May 2019 16:37:45 -0400 Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized…   Read more»

]]> 0d9bad80135c42fdf81b3107a7887ea8 Juan Javier replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10898/ Wed, 15 May 2019 16:37:42 -0400 Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device…   Read more»

]]> f9c82eab40aa743a037307bacab75f7e Juan Javier replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10891/ Wed, 15 May 2019 16:37:37 -0400 Lamiaa: Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working…   Read more»

]]> e29dde42bc22ce0ddc9437fdf0ede532 Juan Javier replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/912/ Mon, 05 Dec 2016 02:10:54 -0500 There is a huge difference between an NDA and a patent. The patent is a federal document utilized to protect and enforce the exclusivity of an idea. An NDA is a contract between two people or a person and an organization. The intent of the NDA, depending on the state, is to limit competition or the dissemination of trade strategies/secrets. The…[Read more]

]]> 0 89c605b1d0dc6346bb43e8a625a20304 Juan Javier replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/910/ Mon, 05 Dec 2016 01:46:56 -0500 I don’t think you have to go too deep into kickback allegations to find some really high profile cases. Take this case with Senator Robert Menendez and his Floridian eye doctor associate.

http://www.businessinsider.com/bob-menendez-defense-fund-took-money-from-developer-jailed-for-kickbacks-2015-4

Where Senator Menendez was indicted on 14…[Read more]

]]> 0 3d61ee7dfb360cda9e3464d0326c2cd3 Juan Javier replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/906/ Mon, 05 Dec 2016 01:41:07 -0500 There is an old adage that a wise engineer once told me; Always, always get everything in writing. Getting things in writing would make everyone’s life easier… But only if the person who prepared that document is ready to devote the required resources. I once had a manager promise the world, but then when I asked if I could get it in writing,…[Read more]

]]> 0 bc6408319fbf697d9ef4313b68519351 Juan Javier replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/771/ Mon, 28 Nov 2016 02:59:49 -0500 I also agree with this. The way managers and directors express their direction promotes the team building within the department. I have experienced both sides of the coin and like you I do prefer the welcoming work culture. Even though all the companies I’ve worked for utilized an organizational matrix, it is really easy to feel left out on a day…[Read more]

]]> 0 762edb7754e31f704fe075eccc810493 Juan Javier replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/770/ Mon, 28 Nov 2016 02:29:57 -0500 I believe that it is much better to work with someone who is knowledgeable and would occasionally give you a tough time than with people who you are highly comfortable with. This way, any potential hurdles/conflicts are handled professionally making you grow as a person. Another benefit is seeing discussion points from another department’s point…[Read more]

]]> 0 2f9c2e064d8e043f885b91f6be5607bf Juan Javier replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/766/ Mon, 28 Nov 2016 02:16:23 -0500 I highly agree with this sentiment. Corporate culture can change in the blink of an eye. I too share the same experience where shuffling management has resulted in a drastic change of perceived job security and camaraderie. However, the amount of completed CAPAs and NCRs were up, as were bonuses. It is certainly interesting to say the least.…[Read more]

]]> 0 7f8af913ba3d78210798506a796d2d67 Juan Javier replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/619/ Mon, 21 Nov 2016 03:18:57 -0500 Usually the quality management system establishes the guidelines to periodically perform a risk assessment. This risk assessment is performed by people who are qualified to perform such activities; an engineer familiar with the device, a quality representative that performs CAPAs and NCRs on said device, and someone from the complaints department…[Read more]

]]> 0 fdf120466a30abb842794dbf447cc2d4 Juan Javier replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/616/ Mon, 21 Nov 2016 03:09:12 -0500 This is a great discussion topic! I believe many of the failures in risk assessment can come from a lack of resources within the company. By resources I mean information and or the personnel required to adequately provide an honest assessment to the medical device. An example would be a poorly managed complaints department at a medical device…[Read more]

]]> 0 f009500de05ad8cb581c866a6f7bc286 Juan Javier replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/614/ Mon, 21 Nov 2016 02:57:02 -0500 As already discussed by others, the best ways are a quality system supported DFMEA matrix, collecting information from various sources such as the complaints department and the past quarter’s CAPAs and NCRs, SWOT analysis and others. I believe the best way on handling the risk identification is to periodically update the assessments every other…[Read more]

]]> 0 abe7f9a9cd1b1c3cedbcc4551fb21405 Juan Javier replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/453/ Mon, 14 Nov 2016 04:56:49 -0500 I believe that Gantt charts are great to keep you in focus with what your deliverables, milestones and project scope should be. In my industry experience, I’ve used Gantt charts to address CAPAs and NCRs. The CAPAs would require a due date set by corporate and you would plan accordingly so that you don’t get stuck with a few headaches down the…[Read more]

]]> 0 21a7e25719746e8fa2db0b452c8d2389 Juan Javier replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/450/ Mon, 14 Nov 2016 04:48:13 -0500 Roberto this is an excellent topic of discussion and as you will find in the field, often a topic of contention. The FDA provides guidelines on how tests should be executed. Take a look at the recent changes to the guidelines for LAL testing and you will see that the FDA does not claim specifics. Another example would be the guidelines to…[Read more]

]]> 0 42ebd6b70eefcb4a62f1bf65b10f2ad3 Juan Javier replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/446/ Mon, 14 Nov 2016 04:42:05 -0500 Even though the lecture cited examples, I would sleep easier knowing validations were done to mitigate risk. Even if there were no changes affecting the human factors of the device, you still need to check the product. What if there are no changes but suddenly an outside factor such as out of control bioburden affects your product? The validations…[Read more]

]]> 0 f7cfddbff99bbff750b8ccae63c2fada Juan Javier replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/254/ Mon, 07 Nov 2016 02:56:34 -0500 Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized in making a medical…[Read more]

]]> 0 b2b2ec84bc27437592159d18c376ed7e Juan Javier replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/249/ Mon, 07 Nov 2016 02:29:38 -0500 Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device as it ensures that the medical device is capable of performing its intended purpose.
It is a method of controlling and…[Read more]

]]> 0 56ac2dbd62d244233c69abb58fcb9f45 Juan Javier replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/240/ Mon, 07 Nov 2016 02:08:35 -0500 Lamiaa:

Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working for a company where any change you wanted to push down the line was stonewalled by other…[Read more]

]]> 0 c8b1efc8259979c744eadea03d503617 Juan Javier became a registered member https://medicaldevicecourses.com/activity/p/222/ Sun, 06 Nov 2016 23:43:13 -0500 0