Heather Carre-Skinner, PhD’s Post

How Consultant In Your Pocket can work for you Somehow we are now in Q4 2024 and now is the perfect time to get your product launch in order and set yourself up for success. Whether you are very early stage and need help understanding what your product needs, or you are looking for expert help with specific compliance questions, here is how Consultant In Your Pocket can work for you: 🔔 Clarify Your Regulatory Pathway  We can work together to identify regulatory requirements for your device and market and develop a plan to meet them, giving you confidence with timelines and budgets.     🔔 Resolve Outstanding Issues  You can use this time to address lingering questions or issues, and have expert answers to any regulatory questions you have, ensuring no stone is left unturned    🔔 Cost-Effective Collaboration  Working with me can save you time and money, as you will leverage my experience to navigate complex regulations efficiently.  We can work flexibly, focusing only on the most critical areas of your business to optimise your budget.     If you are interested to understand more about Consultant In Your Pocket and how the service works, please contact me through DM or email      xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting 

A question for the CEO 💭 Why did you set up your company?   💭 Was it to see your very own product on the market?  💭 Was it to deliver a solution to a problem faced by many in the world?   💭 Was it to feel successful?  💭 Was it to make money?  💭 Was it to feel stressed out and overwhelmed with the journey of getting a product to market?   I speak from experience with running an early-stage company, from investor pitches, creating a lean team and trying to find the right route to market with the budget you have. That is why at Fieldfare we are passionate about helping new companies understand the regulatory landscape for their product and build an efficient and effective launch strategy.  We have the skills and knowledge needed to ensure your success Bespoke regulatory landscape planning  Implementing a Quality Management System  Technical File Compilation  Reduced fee monthly retainer for advice and guidance  xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.  #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting 

A question for the CEO 💭 Why did you set up your company?   💭 Was it to see your very own product on the market?  💭 Was it to deliver a solution to a problem faced by many in the world?   💭 Was it to feel successful?  💭 Was it to make money?  💭 Was it to feel stressed out and overwhelmed with the journey of getting a product to market?   I speak from experience with running an early-stage company, from investor pitches, creating a lean team and trying to find the right route to market with the budget you have. That is why at Fieldfare we are passionate about helping new companies understand the regulatory landscape for their product and build an efficient and effective launch strategy.  We have the skills and knowledge needed to ensure your success 🔔 Bespoke regulatory landscape planning  🔔 Implementing a Quality Management System  🔔 Technical File Compilation  🔔 Reduced fee monthly retainer for advice and guidance  xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting   

A question for the CEO 💭 Why did you set up your company?   💭 Was it to see your very own product on the market?  💭 Was it to deliver a solution to a problem faced by many in the world?   💭 Was it to feel successful?  💭 Was it to make money?  💭 Was it to feel stressed out and overwhelmed with the journey of getting a product to market?   I speak from experience with running an early-stage company, from investor pitches, creating a lean team and trying to find the right route to market with the budget you have. That is why at Fieldfare we are passionate about helping new companies understand the regulatory landscape for their product and build an efficient and effective launch strategy.  We have the skills and knowledge needed to ensure your success 🔔 Bespoke regulatory landscape planning  🔔 Implementing a Quality Management System  🔔 Technical File Compilation  🔔 Reduced fee monthly retainer for advice and guidance  xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting 

A question for the CEO 💭 Why did you set up your company?   💭 Was it to see your very own product on the market?  💭 Was it to deliver a solution to a problem faced by many in the world?   💭 Was it to feel successful?  💭 Was it to make money?  💭 Was it to feel stressed out and overwhelmed with the journey of getting a product to market?   I speak from experience with running an early-stage company, from investor pitches, creating a lean team and trying to find the right route to market with the budget you have. That is why at Fieldfare we are passionate about helping new companies understand the regulatory landscape for their product and build an efficient and effective launch strategy.  We have the skills and knowledge needed to ensure your success 🔔 Bespoke regulatory landscape planning  🔔 Implementing a Quality Management System  🔔 Technical File Compilation  🔔 Reduced fee monthly retainer for advice and guidance     xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting 

A question for the CEO 💭 Why did you set up your company?   💭 Was it to see your very own product on the market?  💭 Was it to deliver a solution to a problem faced by many in the world?   💭 Was it to feel successful?  💭 Was it to make money?  💭 Was it to feel stressed out and overwhelmed with the journey of getting a product to market?   I speak from experience with running an early-stage company, from investor pitches, creating a lean team and trying to find the right route to market with the budget you have. That is why at Fieldfare we are passionate about helping new companies understand the regulatory landscape for their product and build an efficient and effective launch strategy.  We have the skills and knowledge needed to ensure your success 🔔 Bespoke regulatory landscape planning  🔔 Implementing a Quality Management System  🔔 Technical File Compilation  🔔 Reduced fee monthly retainer for advice and guidance   xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.  🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting   

Do you have a product that has to get to market? Do you need to launch on time and within budget? Are you worried that failure could lead to decreased investment and growth in your company? The answer is simple: You need an efficient and effective launch strategy for your product which Fieldfare Consulting can provide you with.  🚀We can work with your budget to determine what market suits your needs  🚀We can provide a clear roadmap of what activities need to be done and when   🚀We can help set up documented processes to follow to satisfy regulatory requirements  🚀We can provide bespoke in-house training so knowledge can be kept within your company  🚀We can help compile any technical file needed for regulatory submissions  At Fieldfare Consulting we have over 15 years' experience in getting products to market.   We understand what is needed. We help innovation thrive. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting  

Are you in the process of implementing a quality system, and are you stuck trying to word the scope so that it’s representative, but still has that bit of “wiggle-room”? Or have you already implemented your quality system and now realise it’s a bloated mess and a complete burden? Getting the scope right can mean your quality system is agile and fit for purpose, or else it’s a bottomless pit of SOPs and forms, and a weight around everyone’s ankles. Here are some pointers: 🚀What are the fundamentals that need to be in the scope? It doesn’t have to be all the products and services that your company has to offer, just the product you are looking to get to market right now. The scope of the quality system can be revised later. 🏆If it’s a medical device you have, does it all need to go under ISO 13485, or can some parts be moved to ISO 9001? Think prototyping vs final device manufacture; there are benefits of having aspects of the business outside of a 13485 system. 🌎How big is your company? Having a wide-reaching quality system will mean more people have to be involved, as well as an increased cost to the business. Ensuring this direction is aligned with the long-term company goals and having buy-in from the CxO’s is gold! 💑Are you looking to have a long and meaningful relationship with your quality system or are you looking for a short exit to market for your product? In each case, the two quality systems could look very different. A short-term strategy can benefit from a good turnkey solution, whereas longer-term may require a system that is more bespoke and in line with company culture.   xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive. 👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech. 🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting

What are the data security risks for my connected medical device?  When customers use connected products, be that medical devices or lifestyle products, they hand over data, which is essential for the product to work as intended. However, there are risks and potential consequences associated with connected devices, and as a manufacturer and user we need to be aware of them.  🔔 Data Breaches: Medical devices store and transmit personal and sensitive data which can be the target of cyberattacks and unauthorised access, so ensuring robust security is key.   🔔 Legacy Systems: We have often seen this in the headlines! Many hospitals etc still use outdated software and operating systems which are no longer supported by the manufacturer, so can contain a multitude of vulnerabilities which can be exploited  🔔 Patient Safety: Not only are there privacy concerns with connected devices, but there is a real risk that hackers can manipulate the functionality of a device which could harm the user, especially if that connected device is providing essential medicine. Remember Medtronics hackable insulin pump!   🔔 Supply chain risks: If the manufacture of a connected device is complex, there are several ways vulnerabilities can be introduced by malicious actors. This is why robust supply management is key!   Of course, this not an exhaustive list of risks and consequences when working with and managing data, but it’s important to recognise the responsibility that manufacturers face. If you have any further questions about what data you process and manage as part of your device, do not hesitate to get in contact.  xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting 

Let’s play Quality Top Trumps   I had a bit of fun and came up with a game to play whilst you wait for the auditor to type up their notes!  I think ISO 9001 is a strong hand to play!    ⭐ ISO 9001: Quality Management System – Requirements  The OG of quality standards. Very customer focused.   ⭐ ISO 13485: Medical devices – Quality Management Systems – Requirements for Regulatory Purposes  It’s needed for nearly every device on the market. It’s so good the US are using it now too!  ⭐ ISO/IEC 27001: Information Security, Cybersecurity and Privacy Protection. Information Security Management Systems – Requirements  It’s very technical, but with all the technology in our lives it will surely be more popular. ⭐ ISO 45001: Occupational Health and Safety Management Systems. Requirements With Guidance for Use  Health and Safety for the win! Plus, it comes with its own guidance for use...bonus!    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 🐦At Fieldfare Consulting we help innovation thrive.  👍We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.   🔊Contact us via DM for further information and help.   #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting