Regulatory Thinking® for Industries
Culture as a leverage to competitive advantage
Even to already established companies, the introduction of new medical products constantly presents new challenges. Moreover, the optimal balancing of effective and efficient workflows as well as meeting regulatory requirements is a daily trade-off, which entrepreneurs and intrapreneurs need to cope with. For companies, as well as for individuals, such as product and quality managers, executives, or consultants, who want to turn regulatory into a competitive advantage and therefore want to implement Regulatory Thinking® as culture in their ventures the consortium offers specific services.
In the following you can get an overview about the solutions for industries and their employees in the categories Education, Hands-on, and Auditing & Reviews of the consortium provides.
Certificate of Advanced Studies Regulatory Thinking
In pharma, medicine and the medtech industry, human beings play the central role. Even if one rightfully thinks of the patient first and the attending physician second in this context, these stakeholders do not yet represent all interest groups that have a legitimate concern for healthcare products.
CAS RT is aimed at (non-)experts in the healthcare business who want to learn why it is important to know about development processes, validation instruments, alternatives in clinical trials, and different certification and reimbursement strategies for medtech, pharma, (digital) biomarkers, in-vitro diagnostics, software or AI as medical device. Participants will become generalists that are highly needed in the changing healthcare sector: Whether you’re a start-up or business leader looking to drive a business forward, a government employee looking to ensure the safety of healthcare products, a payer looking to reimburse healthcare expenses, or defining new reimbursement paths – Regulatory Thinking will teach you how to participate successfully in the healthcare business.
surgeSupply’s team of regulatory experts, medical engineers and experts for digital health can help you design and develop your product. Examples are plans, strategies for software development or help in conducting verification and validation of your product.
Usability Engineering is an integral part of making a good product into a great one. It makes for satisfied users (and with that more sales), less accidents and therefore a safer product. surgeSupply’s team of specialists can help you in user research, planning of usability studies and in drawing up a usability report.
Good risk management decides, if your product is safe enough and therefore is not only important for certification but also for making a device safe to use by the intended user. May it be in the final state – as a certified medical device – or as an investigational device in a clinical investigation. The experts of surgeSupply can help you in drawing up your whole risk management system – from planning, over conducting to writing a risk managemetn report!
From handbooks to SOPs, from ISO 9001 to ISO 13485, SLQ’s documents are available in different document readiness levels. surgeSupply may provides you just with a simple template, basic documentation that just needs the finishing touch or our experts help you drawing up your own personalized documents for you.
What needs to be trained? How do we fit the training in our full schedules? Let surgeSupply help you by providing a training plan that helps you understand the scope and timeframe of all trainings in your company. We also have a solution containing a regulatory calendar that combines a training plan with quizzes for every team member to check if they are up to date.
You want to get going and start working but need a business plan in the regulated field of medical devices? Let surgeSupply’s regulatory and business experts help you by drawing up a business strategy that does not only incorporate regulatory but uses it as an strategical advantage!
Auditing and Reviews
You are ready for design freeze and need a review for your design and development file? Your technical documentation is finished and you are unsure if you pass the conformity assessment? surgeSupply helps you by pre-reviewing and giving you in-depth feedback!
You finished your clinical evaluation and want to be sure it is ready for CE-certification or DiGA application? You want to know if your study is planned sufficiently and is ready for submission? surgeSupply helps you by pre-reviewing and giving you in-depth feedback!
An internal audit is necessary to gain an ISO-certificate. Not only for the ISO 13485 it is a requirement, it is also a chance to get more insight in your own QMS and to see which dial to turn to get the most out of your quality management. The team of surgeSupply helps you by pre-reviewing and giving you in-depth feedback to be sure you have a sufficient PMS and PMCF!
You have a business plan and want to be sure if it is sufficient in terms of regulatory compliance? You want input to achieve fast and economically feasible certification? The team of surgeSupply helps you by pre-reviewing and giving you You have a business plan and want to be sure if it is sufficient in terms of regulatory compliance? You want input to achieve fast and economically feasible certification? Let us help you by pre-reviewing and giving you in-depth feedback!!