{"id":8570,"date":"2023-02-08T15:03:00","date_gmt":"2023-02-08T15:03:00","guid":{"rendered":"https:\/\/uic.se\/?post_type=partner&p=8570"},"modified":"2025-04-17T12:27:03","modified_gmt":"2025-04-17T10:27:03","slug":"regsmart","status":"publish","type":"partner","link":"https:\/\/uic.se\/en\/partner\/regsmart\/","title":{"rendered":"RegSmart Life Science"},"content":{"rendered":"\n
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RegSmart Life Science AB is a regulatory consultancy firm that can help you navigate in a complex and evolving regulatory landscape. With our combined regulatory experience from senior positions at the Swedish MPA (L\u00e4kemedelsverket) and from small and big life science companies we can facilitate your work by knowing what to do, when and how.<\/p>\n<\/div>\n\n\n\n

\"Regsmart-logo-color-RGB\"<\/figure><\/div>\n<\/div>\n\n\n\n
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We advise and support in relation to European and US regulatory requirements, can help you develop a regulatory plan as part of your overall project strategy. Our expertise is to analyze and interpret the guidance provided and decisions taken by regulatory agencies in both EU and US to help answer specific questions in your projects. We provide support from early research throughout your product’s life-cycle, always with the final product in mind.<\/p>\n<\/div>\n\n\n\n

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RegSmart<\/h3>\n\n\n\n

Eklundshovsv\u00e4gen 5<\/p>\n\n\n\n

Uppsala<\/p>\n\n\n\n

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info@regsmart.se<\/a><\/p>\n\n\n\n

regsmart.se<\/a><\/strong><\/p>\n\n\n\n

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Mats H\u00f6gberg<\/h4>\n\n\n\n

Contact for UIC companies<\/p>\n\n\n\n

mats.hogberg@regsmart.se<\/a><\/p>\n\n\n\n

070-5465021<\/p>\n\n\n\n

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For entrepreneurs and early start-up companies in the Life Sciences arena, enrolled in any of UIC\u00b4s Business Programs RegSmart Life Science AB offers standardized packages for reduced fees.<\/h3>\n\n\n\n

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\u2022 Initial Set-The-Stage meeting <\/strong><\/p>\n\n\n\n

Specific Q&A session regarding your innovation with the purpose to understand the regulatory landscape and your place in it.<\/p>\n\n\n\n


\u2022 Package 1 \u2013 Qualification <\/strong><\/p>\n\n\n\n

After completing this package you will have a basic understanding of how the regulatory requirements affect the development and commercialization of your innovation. It will help you plan your next steps in a way that is both efficient and compliant with current regulations.<\/p>\n\n\n\n


\u2022 Package 2 \u2013 Classification <\/strong><\/p>\n\n\n\n

In this package we determine the exact regulatory requirements applicable to your product in accordance with its classification based on risk. You will receive an overview of the different steps that the product must go through to meet these requirements. Furthermore, we provide guidance on the relevant regulations and standards that should be applied to the product in accordance with its classification.<\/p>\n\n\n\n


\u2022 Package 3 \u2013 Quality Management <\/strong><\/p>\n\n\n\n

We offer our support in implementing a QMS that perfectly fits your organization, adapted to your innovation and your target market. Whether you already have a partially established QMS or you are starting from scratch, we can help you on your journey to compliance and higher quality. This can include training existing staff to manage change or teaching new staff how to establish and maintain a new QMS. For those of you that are interested in introducing an electronic QMS, we can also assist in the procurement and implementation of such a system.
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Each of the packages is further described below.
For further information, please contact Mats H\u00f6gberg<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Initial Set-the-Stage meeting, 1 hour<\/strong><\/h3>\n\n\n\n

Initial meeting, where the entrepreneur or start-up company presents their innovation or idea to an expert from RegSmart.
The expert will ask questions about the product and provide advice on not only the possible regulatory path but also on suggested adjustments of business model, channel strategy, target customer, etc. that might lessen the regulatory challenge.<\/p>\n\n\n\n

Free of charge<\/strong><\/em><\/p>\n<\/div>\n\n\n\n

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Package 1 – Qualification<\/strong><\/h3>\n\n\n\n

Step 1 \u2013 at the customer \u2013 Intro and presentation of innovation<\/strong>
\u2022 A start-up meeting with a walk-through of the innovation (told by the customer) and their business plan.
\u2022 What is the intended purpose?
\u2022 Is the product a medical device, diagnostic, combination product or something else?
\u2022 Who is the intended user, professional or consumer?
\u2022 What does the device contain\/entail?
\u2022 What is the development phase of the device (concept, prototype, patient test, clinical evaluation)?
\u2022 What is the clinical benefit of the device?<\/p>\n\n\n\n


Step 2 \u2013 at RegSmart \u2013 Analysis of regulatory arena<\/strong>
\u2022 Analysis of the device’s potential from a regulatory perspective.
\u2022 Qualification of the device based on its clinical benefit.
\u2022 What legislation might the device be subject to?
\u2022 Additional legislation that may be useful depending on the use of the device and intended users.
\u2022 Short explanatory summaries
\u2022 Drafting of report for the customer.<\/p>\n\n\n\n


Step 3 – Conclusion and report<\/strong>
\u2022 Handover of the report.
\u2022 Closing meeting with walk-through of the report and time for questions from the customer.<\/p>\n\n\n\n

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Cost: 39.000 SEK<\/strong><\/em><\/p>\n<\/div>\n\n\n\n

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Package 2 – Classification<\/h3>\n\n\n\n

Step 1 \u2013 with the customer
<\/strong>\u2022 Review of product development phase (concept, prototype, clinical investigation, clinical evaluation, usability).
\u2022 What is the goal?
\u2022 Are there external suppliers that will manufacture the device?
\u2022 Financial situation, cost expectations and estimations regarding certification, approval and\/or clearance.<\/p>\n\n\n\n


Step 2 \u2013 at RegSmart<\/strong>
\u2022 Justified risk classification.
\u2022 Applicable directives and regulations.
\u2022 Standards and regulations that may be applicable.
\u2022 Additional legislation that may be useful depending on the use of the device and intended users.
\u2022 Quality management requirements. (ISO 13485)
\u2022 Road to market, an overview of the different stages of development of a medical device.
\u2022 At what developmental stage is the product now and what is a reasonable next step?
\u2022 Drafting of report for the customer.
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Conclusion and report<\/strong>
\u2022 Handover of the report.
\u2022 Closing meeting with walk-through of the report and time for questions from the customer.<\/p>\n\n\n\n

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Cost: 49.000 SEK<\/em><\/strong><\/p>\n<\/div>\n\n\n\n

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Package 3 – Quality Management<\/h3>\n\n\n\n

Step 1 \u2013 at the customer’s premises<\/strong>
\u2022 Inventory of needs.
\u2022 The size of the company?
\u2022 Manufacturer, distributor, authorized representative, or several of these roles?
\u2022 Devices under development or in operation?
\u2022 What is the timeline for non-operational devices?
\u2022 Is there a QMS that needs to be migrated? Is it done by us or by the customer?
\u2022 Is there historical documentation that needs to be migrated? Is it done by us or the customer?
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Step 2 \u2013 at RegSmart<\/strong>
\u2022 Basic QMS (analogue).
\u2022 Customization of templates for the customer
\u2022 Complementing with customer-specific processes.
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Step 3 \u2013 at the customer’s premises<\/strong>
\u2022 Training of staff
\u2022 Implementation of QMS
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Ancillary services<\/strong>
1. Procurement of Notified Body for ISO certification
2. PRRC (priced based on availability and at least 16h\/month of active work)<\/p>\n\n\n\n

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Cost: Ask for quote<\/em><\/strong><\/p>\n<\/div>\n\n\n\n

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