Medical Device Courses | tme3 | Activity https://medicaldevicecourses.com/members/tme3/activity/ Activity feed for tme3. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 43a215045cdea942105e2226e8026377 tme3 replied to the topic "CROs" - https://medicaldevicecourses.com/activity/p/12527/ Wed, 15 May 2019 16:56:46 -0400 Using a CRO can usually over an objective assessment to a company when it comes to its drug/device and the resultant outcomes. CROs are usually well versed in conducting and managing clinical trials set forth by a company. This is…   Read more»

]]> acd9d5a45c1752883e808b4b0c124e50 tme3 replied to the topic "Clinical Study Location/cost vs. results" - https://medicaldevicecourses.com/activity/p/12525/ Wed, 15 May 2019 16:56:45 -0400 Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the article listed below, India has become a popular location in conducting these clinical trials due to the…   Read more»

]]> 0e6ff8383b170fa0a8db57adeb01e86d tme3 replied to the topic "Internal Audits for small organizations" - https://medicaldevicecourses.com/activity/p/12442/ Wed, 15 May 2019 16:56:05 -0400 In my experience, a contractor is usually hired or an external auditor is hired for such occasions. This is standard practice if no resources are made available from within the organization.

]]> 0041d10e2be14579229f5a5ea318082a tme3 replied to the topic "Audits" - https://medicaldevicecourses.com/activity/p/12441/ Wed, 15 May 2019 16:56:04 -0400 I think that internal audits can help streamline a business and find problems that perhaps a lax enviornment has perpetuated. Internal audits are more effeicient and can help spot problems in application of SOPs, safety hazards or even documentation control.

]]> 65a83144ab188b3cdf3f94504a3db796 tme3 replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" - https://medicaldevicecourses.com/activity/p/12350/ Wed, 15 May 2019 16:55:12 -0400 I feel that existing product and documentation should be grandfathered in, since the time and money to extend these changes could lead down a many different paths and endless changes, revisions and updates. Projects that have been started already should…   Read more»

]]> 0e18b4930a079eceb682f4d4dfb8505e tme3 replied to the topic "No GMPs" - https://medicaldevicecourses.com/activity/p/12349/ Wed, 15 May 2019 16:55:12 -0400 I feel GMPs purpose is noble, but in practice it is more of a hassle to a company rather than a benefit to a consumer. GMPs can force companies to take the necessary measures, but I feel that most companies…   Read more»

]]> 60a757bfcbfc873a7a0bff79fa2f4101 tme3 replied to the topic "Discussion Topic: Vagueness of GMP's" - https://medicaldevicecourses.com/activity/p/12347/ Wed, 15 May 2019 16:55:11 -0400 I feel the ambiguity does just that, provide a framework for these companies. Since there is at least a base in place, each company can then place their own quality and SOP in order to comply to GMP’s. Each business/company…   Read more»

]]> 9b78704b94a5c18bf04d0bf231b87b8f tme3 replied to the topic "Types of Validation" - https://medicaldevicecourses.com/activity/p/11967/ Wed, 15 May 2019 16:51:31 -0400 One interesting form of validation I have performed before is surgeon validation as the end user. Working with specialty medical instruments, our clients were the physicians who gave us specifics of each individual instrument or implant. This could range from…   Read more»

]]> a7642052765f3920d9f28f2f422a506a tme3 replied to the topic "Discussion Topic: Playing with IQ, OQ, PQ" - https://medicaldevicecourses.com/activity/p/11966/ Wed, 15 May 2019 16:51:31 -0400 Hi Viraj, I agree with your approach but I believe you can to the following points: IQ – In addition to the manuals, you should call out maintenance and calibration schedules as well as procedural protocols for the entire process….   Read more»

]]> d46d244d318d4d5383854ca261165757 tme3 replied to the topic "Process Revalidation" - https://medicaldevicecourses.com/activity/p/11965/ Wed, 15 May 2019 16:51:30 -0400 I’ve had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation for all aspects of the process moving. While you can and successfully argue with and rationalize certain aspects…   Read more»

]]> 24077f3415b55e5525429b98efc504cb tme3 replied to the topic "DHF vs. DHR" - https://medicaldevicecourses.com/activity/p/11831/ Wed, 15 May 2019 16:50:10 -0400 As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintains manufacturing, sterilization, QC as well as produced quantities of any specific lot…   Read more»

]]> 9316691a50c1c9016e4d59ab24c8dc34 tme3 replied to the topic "Standard Operating Procedures (SOP's)" - https://medicaldevicecourses.com/activity/p/11830/ Wed, 15 May 2019 16:50:10 -0400 If the product or process is still in a research phase or even development phase an SOP is needed either way. This is to ensure the tests are as repeatable as possible as was stated above and also to ensure…   Read more»

]]> 78b381f43ee33fdcf7694ea2681450bb tme3 replied to the topic "SOP: how much detail before too much detail?" - https://medicaldevicecourses.com/activity/p/11829/ Wed, 15 May 2019 16:50:09 -0400 Chris, I see this all the time on both ends of the spectrum when reviewing SOPs. There are protocols that lack any clear directions and leave much of the interpretation up to the test engineer while others leave very little…   Read more»

]]> 0028622e208d84075537198eefddc2bf tme3 replied to the topic "Regression Verification and Validation" - https://medicaldevicecourses.com/activity/p/11703/ Wed, 15 May 2019 16:48:52 -0400 In an failed V&V testing portion of a new product could point to many factors such as poor design, test method, test operators or as you suggested a product simply not able to meet a spec. If a root-cause analysis…   Read more»

]]> c4a0f09f911825f270e483e0336f038e tme3 replied to the topic "Discussion Topic: Is the DHF a living document?" - https://medicaldevicecourses.com/activity/p/11676/ Wed, 15 May 2019 16:48:38 -0400 I believe that the DHF should be a living document. This is due to the fact that many other components of a product may be interlinked. If any part of this product were to change, the DHF should be updated…   Read more»

]]> cecf8a3d27f37484d631665b0472adb4 tme3 replied to the topic "DHF vs. Tech File/Design Dossier" - https://medicaldevicecourses.com/activity/p/11675/ Wed, 15 May 2019 16:48:38 -0400 I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification…   Read more»

]]> 46e3b68b36f3617a1d23056eeaa0b72a tme3 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11335/ Wed, 15 May 2019 16:44:01 -0400 This course has been very helpful in looking at some of the other areas of the medical device industry that I have not been exposed to. Not only that, but the interaction between other students with lab experience or work…   Read more»

]]> 5d8fc6fc5988e9aedc3ce7de0df64f97 tme3 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11203/ Wed, 15 May 2019 16:40:59 -0400 Currently, I work for a company that employs the functional organization structure. This helps in allowing all the smaller specialized groups to focus on our certain tasks at any specific point of a project. For instance, in R&D I’m solely…   Read more»

]]> 9ace6fe5f16dfd41a9fae899f4d5de95 tme3 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11201/ Wed, 15 May 2019 16:40:57 -0400 Hi, Looking at these different types, the last one in particular stands out to me for certain reasons. First, the fact that the directorate have an influential vision that is applied across the company and its different branches. This circular…   Read more»

]]> 574e890dbef9c7721fdbc13ec30643a4 tme3 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11060/ Wed, 15 May 2019 16:39:32 -0400 I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that subscribers will always have access to these articles…   Read more»

]]> d963fb59ce8f2cb9814c6305c8dd8cc6 tme3 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11059/ Wed, 15 May 2019 16:39:31 -0400 Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. There are many different…   Read more»

]]> 6c436a39c4419a7205719d65183b2a50 tme3 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10813/ Wed, 15 May 2019 16:36:49 -0400 An interesting standpoint on design control is that they protect against product liability of design defect. Design defect is concerned with claiming the safety of the product is in doubt and that the route taken to design said product, neglected…   Read more»

]]> f48c0939332964485648d15f93db1a86 tme3 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10812/ Wed, 15 May 2019 16:36:48 -0400 I think its difficult to pinpoint a single portion of a DDP to be as the most crucial as all portions are critical to a project’s success. To answer your question, a gantt chart is a very important in terms…   Read more»

]]> 6710c8942f72d170cdd71df4812282e0 tme3 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10807/ Wed, 15 May 2019 16:36:46 -0400 Yes, while a DHF is not needed for an EU release product, design controls are still an integral part of the process and are still integral. While that may be the case, I believe any company looking to expand its…   Read more»

]]> c224e0ea76816d2f4f273151ad92806e tme3 replied to the topic CROs in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2429/ Mon, 24 Apr 2017 04:12:39 -0400 Using a CRO can usually over an objective assessment to a company when it comes to its drug/device and the resultant outcomes. CROs are usually well versed in conducting and managing clinical trials set forth by a company. This is usually a better round to recieve sound and unbiased feedback and regulated control of a clinical trial.

]]> 0 09a5f99c5f037aa51b3fcc390357eafa tme3 replied to the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2427/ Mon, 24 Apr 2017 03:59:01 -0400 Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the article listed below, India has become a popular location in conducting these clinical trials due to the cost, about 20-60% if done locally.…[Read more]

]]> 0 2f10868495e5d9c01fbd049d396328ce tme3 replied to the topic Internal Audits for small organizations in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2311/ Mon, 17 Apr 2017 03:52:15 -0400 In my experience, a contractor is usually hired or an external auditor is hired for such occasions. This is standard practice if no resources are made available from within the organization.

]]> 0 b822427464c411a9c9163111c7e1d9c2 tme3 replied to the topic Audits in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2310/ Mon, 17 Apr 2017 03:47:49 -0400 I think that internal audits can help streamline a business and find problems that perhaps a lax enviornment has perpetuated. Internal audits are more effeicient and can help spot problems in application of SOPs, safety hazards or even documentation control.

]]> 0 e02c4e64d837abefbcb3b0ec2f7f9ad8 tme3 replied to the topic Discussion Topic: When Quality Systems change in the middle of a project in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2202/ Mon, 10 Apr 2017 03:30:59 -0400 I feel that existing product and documentation should be grandfathered in, since the time and money to extend these changes could lead down a many different paths and endless changes, revisions and updates. Projects that have been started already should be assessed on a case by case basis. A risk analysis should be done to determine if these…[Read more]

]]> 0 d6e98e0eb525ad9c159f60ac90a13187 tme3 replied to the topic No GMPs in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2201/ Mon, 10 Apr 2017 03:27:59 -0400 I feel GMPs purpose is noble, but in practice it is more of a hassle to a company rather than a benefit to a consumer. GMPs can force companies to take the necessary measures, but I feel that most companies today adhere to these standards regardless of GMPs. this can be a result of the existing framework or maybe this is necessary to keep these…[Read more]

]]> 0 8337cb552fc1dc42fef00a6dfd31606f tme3 replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2198/ Mon, 10 Apr 2017 03:16:54 -0400 I feel the ambiguity does just that, provide a framework for these companies. Since there is at least a base in place, each company can then place their own quality and SOP in order to comply to GMP’s. Each business/company is different in its manufacturing process and products, so applying a strict set of rules would hinder growth in the industry…[Read more]

]]> 0 573a2384f250171c9e1e9e75b46ca8d7 tme3 replied to the topic Types of Validation in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1712/ Sun, 26 Feb 2017 23:18:19 -0500 One interesting form of validation I have performed before is surgeon validation as the end user. Working with specialty medical instruments, our clients were the physicians who gave us specifics of each individual instrument or implant. This could range from custom sizes, to longer/short instruments or even something as simple as changing a grip…[Read more]

]]> 0 d226b4324356fc26b6144e9301216b4f tme3 replied to the topic Discussion Topic: Playing with IQ, OQ, PQ in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1711/ Sun, 26 Feb 2017 23:14:34 -0500 Hi Viraj,

I agree with your approach but I believe you can to the following points:

IQ – In addition to the manuals, you should call out maintenance and calibration schedules as well as procedural protocols for the entire process.

OQ- I believe the OQ should determine your maximum operational window for two things, the application of the…[Read more]

]]> 0 f603a937f6117e8f8752f6fa6280e157 tme3 replied to the topic Process Revalidation in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1710/ Sun, 26 Feb 2017 23:05:32 -0500 I’ve had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation for all aspects of the process moving. While you can and successfully argue with and rationalize certain aspects of a complete revalidation, I believe it is always worth mitigating risk and going…[Read more]

]]> 0 bfd1cf36bb2860cdb08b63f849735c89 tme3 replied to the topic DHF vs. DHR in the forum Device Documentation https://medicaldevicecourses.com/activity/p/1536/ Mon, 13 Feb 2017 13:50:27 -0500 As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintains manufacturing, sterilization, QC as well as produced quantities of any specific lot number of 1 time use medical devices or the complete traceability of implants and multi-use medical devices.

]]> 0 4d898fa1fbfa3f0546d522d9799a9776 tme3 replied to the topic Standard Operating Procedures (SOP's) in the forum Device Documentation https://medicaldevicecourses.com/activity/p/1535/ Mon, 13 Feb 2017 13:47:36 -0500 If the product or process is still in a research phase or even development phase an SOP is needed either way. This is to ensure the tests are as repeatable as possible as was stated above and also to ensure that a documented test method is available to go hand in hand with any applicable results. This allows the SOP to develop along side the…[Read more]

]]> 0 9fd8cd1d80f74ce211ad1bb21d93f0df tme3 replied to the topic SOP: how much detail before too much detail? in the forum Device Documentation https://medicaldevicecourses.com/activity/p/1534/ Mon, 13 Feb 2017 13:43:12 -0500 Chris,

I see this all the time on both ends of the spectrum when reviewing SOPs. There are protocols that lack any clear directions and leave much of the interpretation up to the test engineer while others leave very little room for any sort of deviation. In my experience, the more detail the better since the procedure must be repeatable for any…[Read more]

]]> 0 9c6986e155956473f42b6b92bd4cc90a tme3 replied to the topic Regression Verification and Validation in the forum The Design History File https://medicaldevicecourses.com/activity/p/1360/ Sun, 05 Feb 2017 22:46:09 -0500 In an failed V&V testing portion of a new product could point to many factors such as poor design, test method, test operators or as you suggested a product simply not able to meet a spec. If a root-cause analysis of these failures indicate that the cause of the problem is indeed the spec, then it is early enough in the life of the product to…[Read more]

]]> 0 91dbe845881df274e470e57d54d82ce8 tme3 replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File https://medicaldevicecourses.com/activity/p/1329/ Fri, 03 Feb 2017 18:58:12 -0500 I believe that the DHF should be a living document. This is due to the fact that many other components of a product may be interlinked. If any part of this product were to change, the DHF should be updated to reflect this. Whether it be a material change, a tolerance adjustment or a simple process parameter update all these are minor (or major!)…[Read more]

]]> 0 6f26171647f0259f000129b6f6f2e2e6 tme3 replied to the topic DHF vs. Tech File/Design Dossier in the forum The Design History File https://medicaldevicecourses.com/activity/p/1328/ Fri, 03 Feb 2017 18:54:09 -0500 I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification and validation. These are very valuable in terms of building a product from start to finish with all the associated files.…[Read more]

]]> 0 d2524ac533a022e0c179c3fb661086a2 tme3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/814/ Wed, 30 Nov 2016 15:56:27 -0500 This course has been very helpful in looking at some of the other areas of the medical device industry that I have not been exposed to. Not only that, but the interaction between other students with lab experience or work experience has helped in giving me different perspectives on certain issues.

]]> 0 7ea20a4eb05b8b1bb6ee71d36c8ecac8 tme3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/656/ Tue, 22 Nov 2016 16:33:31 -0500 Currently, I work for a company that employs the functional organization structure. This helps in allowing all the smaller specialized groups to focus on our certain tasks at any specific point of a project. For instance, in R&D I’m solely engrossed in working and developing any direct engineering work for said project. What I mean by this is, I h…[Read more]

]]> 0 6796b8a5bf50a7caea095ad969f4fc80 tme3 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/654/ Tue, 22 Nov 2016 15:56:59 -0500 Hi,
Looking at these different types, the last one in particular stands out to me for certain reasons. First, the fact that the directorate have an influential vision that is applied across the company and its different branches. This circular organization also allows for sharing of workload and responsibility between different divisions of the…[Read more]

]]> 0 0c729aa20a1c04c31fccde16f115939f tme3 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/464/ Mon, 14 Nov 2016 16:27:53 -0500 I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that subscribers will always have access to these articles and the subscriber will continue to pay an annual fee. In theory this should fund future work on…[Read more]

]]> 0 bef7955c3f98e5d4f217a53639822ce3 tme3 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/463/ Mon, 14 Nov 2016 16:21:45 -0500 Fortunately I have had the opportunity to sit in on risk analysis session for a new product. The amount of time and effort that goes into creating the EURA’s (End User Risk Analysis) is very great. There are many different functions to look at when it comes to creating your EURA’s such as Process, Design, and Application. Like you mentioned bef…[Read more]

]]> 0 5749f36db10e63d50dc9255c7aee5596 tme3 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/105/ Wed, 02 Nov 2016 20:06:07 -0400 An interesting standpoint on design control is that they protect against product liability of design defect. Design defect is concerned with claiming the safety of the product is in doubt and that the route taken to design said product, neglected to account for product safety or make a safer design. With the use of design control, specifically…[Read more]

]]> 0 caafcf76c2f442f2dc3520e2c64e6a3b tme3 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/104/ Wed, 02 Nov 2016 20:00:36 -0400 I think its difficult to pinpoint a single portion of a DDP to be as the most crucial as all portions are critical to a project’s success. To answer your question, a gantt chart is a very important in terms of outlining the tasks related to the project, the responsible party for each portion as well as the expected timeline to completion. The…[Read more]

]]> 0 38842e291cc91f43f569c1b998f457e5 tme3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/93/ Tue, 01 Nov 2016 15:50:36 -0400 Yes, while a DHF is not needed for an EU release product, design controls are still an integral part of the process and are still integral. While that may be the case, I believe any company looking to expand its platform to an international level, can always beneifit from “over documentation” and having a DHF on hand and constantly updated. This…[Read more]

]]> 0