RegSmart Life Science AB är ett regulatoriskt konsultföretag som kan hjälpa dig att navigera i ett komplext och föränderligt regulatoriskt landskap. Med vår kombinerade regulatoriska erfarenhet från ledande befattningar på Läkemedelsverket och från små och stora life science-företag kan vi underlätta ditt arbete genom att veta vad du ska göra, när och hur.
Vi ger råd och stöd i förhållande till europeiska och amerikanska regulatoriska krav, kan hjälpa dig att utveckla en regulatorisk plan som en del av din övergripande projektstrategi. Vår expertis är att analysera och tolka den vägledning som tillhandahålls och beslut som tas av tillsynsmyndigheter i både EU och USA för att hjälpa dig att svara på specifika frågor i ditt projekt. Vi tillhandahåller stöd från tidig forskning under hela din produkts livscykel, alltid med slutprodukten i åtanke.
RegSmart
Eklundshovsvägen 5
Uppsala
Mats Högberg
Kontakt för UIC-bolagen
mats.hogberg@regsmart.se
070-5465021
For entrepreneurs and early start-up companies in the Life Sciences arena, enrolled in any of UIC´s Business Programs RegSmart Life Science AB offers standardized packages for reduced fees.
• Initial Set-The-Stage meeting
Specific Q&A session regarding your innovation with the purpose to understand the regulatory landscape and your place in it.
• Package 1 – Qualification
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.
• Package 2 – Classification
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.
• Package 3 – Quality Management
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.
Each of the packages is further described below.
For further information, please contact Mats Högberg
Initial Set-the-Stage meeting, 1 hour
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.
Free of charge
Package 1 – Qualification
Step 1 – at the customer – Intro and presentation of innovation
• A start-up meeting with a walk-through of the innovation (told by the customer) and their business plan.
• What is the intended purpose?
• Is the product a medical device, diagnostic, combination product or something else?
• Who is the intended user, professional or consumer?
• What does the device contain/entail?
• What is the development phase of the device (concept, prototype, patient test, clinical evaluation)?
• What is the clinical benefit of the device?
Step 2 – at RegSmart – Analysis of regulatory arena
• Analysis of the device’s potential from a regulatory perspective.
• Qualification of the device based on its clinical benefit.
• What legislation might the device be subject to?
• Additional legislation that may be useful depending on the use of the device and intended users.
• Short explanatory summaries
• Drafting of report for the customer.
Step 3 – Conclusion and report
• Handover of the report.
• Closing meeting with walk-through of the report and time for questions from the customer.
Cost: 39.000 SEK
Package 2 – Classification
Step 1 – with the customer
• Review of product development phase (concept, prototype, clinical investigation, clinical evaluation, usability).
• What is the goal?
• Are there external suppliers that will manufacture the device?
• Financial situation, cost expectations and estimations regarding certification, approval and/or clearance.
Step 2 – at RegSmart
• Justified risk classification.
• Applicable directives and regulations.
• Standards and regulations that may be applicable.
• Additional legislation that may be useful depending on the use of the device and intended users.
• Quality management requirements. (ISO 13485)
• Road to market, an overview of the different stages of development of a medical device.
• At what developmental stage is the product now and what is a reasonable next step?
• Drafting of report for the customer.
Conclusion and report
• Handover of the report.
• Closing meeting with walk-through of the report and time for questions from the customer.
Cost: 49.000 SEK
Package 3 – Quality Management
Step 1 – at the customer’s premises
• Inventory of needs.
• The size of the company?
• Manufacturer, distributor, authorized representative, or several of these roles?
• Devices under development or in operation?
• What is the timeline for non-operational devices?
• Is there a QMS that needs to be migrated? Is it done by us or by the customer?
• Is there historical documentation that needs to be migrated? Is it done by us or the customer?
Step 2 – at RegSmart
• Basic QMS (analogue).
• Customization of templates for the customer
• Complementing with customer-specific processes.
Step 3 – at the customer’s premises
• Training of staff
• Implementation of QMS
Ancillary services
1. Procurement of Notified Body for ISO certification
2. PRRC (priced based on availability and at least 16h/month of active work)
Cost: Ask for quote