Medical Innovations Incubator
Home of 4C - Enabling Life Science Innovations
We are official Pre-Seed partner of the federal state BW.
Get up to 200.000 € here!
- Regulatory Thinking® was developed specifically for medical innovations
- Regulatory Thinking® – these are tools, processes and thinking approaches that can help to develop a convincing business model in this complex sector.
- Regulatory Thinking® combines regulatory topics with business modeling – two seemingly incompatible worlds.
- Regulatory Thinking® is your competitive advantage as you develop your business model from a regulatory perspective
E.g.: Our “Regulatory Canvas” combines Business Model Canvas + Design Thinking + Personas + Patient Journeys via the lens of regulatory requirements for medical innovation.
For more information: firstname.lastname@example.org
Research and Teaching
Besides the funded 4C Accelerator program we offer our support via start-up centred seminars, filled out templates and individual workshops. All these services are made “by startups for startups” and are highly customizable to your specific product.
In our experience, startups buy regulatory affairs knowledge at a high price, for example in the form of consulting hours and templates. Our in-depth offerings focus on helping you to help yourselfe and are intended to gain speed in small digestible packages regarding setting up a quality management system and creating the product file (Technical File). In particular, we would like to ENABLE you to develop your own way of thinking in order to be able to evaluate further support independently.
Quality Management System (QMS)
Design of a process landscape | 0,5 Day workshop
- Together we set up a project plan for the structured implementation of a quality management system according to ISO 13485.
- Generates a common vision of this complex topic across disciplines in the team – the basis for traction!
- Develop your individual process landscape as a basis for the implementation of your quality management system – based on the Medical Innovations Incubator (MII) standard process landscape for startups.
Quality Management System Template Package | Product
- We offer a corresponding MII template package which matches the process landscape.
- Contains a basic version of a QMS manual.
- More than just “templates”: Each Standard Operation Procedure (SOP) and Work Instruction (WI) already contains valuable information (instructions, customizable content, forms, references, basic content).
- The product is designed to grow with your startup and its structures.
- To guarantee optimized implementation, our hands-on consulting hours are included.
- Consultation on selecting eQMS software to organize QMS documentation files or alternative ways to build a document governance structure.
- Product can also be combined with our “Manual Package”.
Quality Management System Manual Package | Product
- The very special approach to implement a QMS. Especially for startups that (want to) get into the topic early!
- Consists of an extremely comprehensive QMS manual, which includes all required elements of ISO 13485.
- An individual derivation of Standard Operation Procedures (SOP) and Work Instructions (WI) thus becomes child’s play.
- Includes key checklists and questionnaires, one template for standard SOPs and advice on selecting eQMS software to organize QMS documentation files.
QA/RA Manager | Training (2 days)
- This qualification serves as a basic requirement to be able to take over QA/RA tasks, to have an overview of functions and to understand the interrelationships.
- The focus is on the establishment of a functioning QMS, the rights and duties of a QA/RA manager and an overview of relevant norms and standards.
- Together, we will place this strategic role in your company’s organizational structure and develop a job description.
- The result is an overall understanding of the principles and requirements for setting up, maintaining and developing a quality management system and everything related to it.
- After the 2 days of the workshop, the participants will be able to take over a responsible QA/RA role in their (own) startup.
Applicant Evaluation for QA/RA Manager | Service
- You are looking for a person with the right QA/RA qualifications?
- We help you identify the right QA/RA personality.
Interim QA/RA Manager | Service
- You want to start with your QMS, but don’t have the right resource in your team yet?
- We can take over the QA/RA tasks and responsibilities (e.g. PRRC) as interim manager.
Get to know a Notified Body and Certification Body | Service
- Lecture and individual discussion with Lead Auditor, Lead Technical Assessor, Certification Body or Notified Body.
- The focus is on understanding the requirements of a Notified Body and getting personal feedback regarding your own startup.
Technical documentation / CE approval
Establishing a project structure for the creation of technical documentation | 0.5 day workshop
- We start with a theoretical input before it gets practical immediately. We develop your individual plan based on the MII standard project plan, which was developed especially for startups.
- From the initiation of your project “approval as a medical device” to the submission of the technical documentation to a notified body, we will discuss your case and develop an individual project plan.
- Of course, best practices on project management are also included.
Intended Use Definition | one day workshop
- By systematically and professionally defining the intended use, many questions become answers and you can focus on the essential content of your project.
- In a workshop format, we develop content (e.g. indication, therapy method, patient population, user population) for the strategically most central document on the way to CE marking – the purpose statement.
- For this we use the “MII-Intended-Use-Basic Documentation”.
- The derivation of strategic tasks for the company departments affected by the workshop results (e.g. legal, marketing) is one of our areas of expertise.
Clinical Evaluation | Template Package (Product)
- Special template package for a central part of the technical documentation.
- Contains templates of all relevant Clinical Evaluation documents that have to be provided by the manufacturer for the conformity assessment for the product approval at a notified body.
Technical Documentation (Technical File) | Template Package (Product).
- Contains templates of all relevant development documents that must be provided by the manufacturer for conformity assessment for product approval at a notified body.
- We are guided by the requirements from Annex II of MDR (EU) 2017/745 and the requirements for a STED.
Risk Management and Usability Engineering
Building and establishing a risk management system according to ISO 14971 | one day workshop
- Together we lay the foundations for establishing a risk management file in accordance with the requirements of ISO 14971 and ISO 13485 and MDR (EU) 2017/745.
- Together we identify risk impact types, evaluate risks, classify them and define acceptance criteria.
- At the end of the workshop, we recognize the strategic benefits of successful risk management and understand how this approach extends to all areas of the business (e.g. risk analysis for decision making).
- The offer also includes templates and instructions for practical implementation in the individual case of your startup.
Risk Management | Template Package (Product)
- Contains templates for all relevant risk management documents that have to be provided by the manufacturer for the conformity assessment for the product approval at a notified body.
Setting up and establishing usability engineering according to IEC 62366 | 0.5 day workshop
- Together we will lay the foundations for the establishment of usability engineering processes according to the IEC 62366 specification for the creation of a usability file, which is mandatory for your technical documentation.
- In doing so, we go deep into describing the context of use, develop initial usability analyses, specify requirements for the product derived from these, and learn how to verify and validate these requirements.
- Includes some templates for relevant usability engineering documents that must be provided by the manufacturer for conformity assessment for product approval at a notified body.
Usability Engineering | Template Package (Product)
- Contains templates of all relevant usability engineering documents that have to be provided by the manufacturer for conformity assessment for product approval at a notified body.
Less time, cost and anxiety with critical institutions thanks to our reviews!
#Notified Body #Ethics Committee #Study Center
In our experience, institutions that are in high demand, such as notified bodies, ethics committees and study centers, tend to see their responsibility less in advising startups and improving their documents. Even establishing a first contact is often a major challenge. This makes it all the more important to maximize the chances of success for upcoming appointments and document reviews by these institutions in advance in order to save time and costs.
The MII and its partners support you in this process via the following pre-assessments and audits. If we determine during the process that you are prepared to contact an authority, we can, if requested, approach our contacts there to expedite your application.
1. QMS – Internal audit prior to initial contact with Notified Body
We know: The first contact with the Certification Body / Notified Body makes sense only when the quality management system (QMS) is 50% completed + your management review + your internal audit is finished, because it facilitates their scheduling and saves you unnecessary costs for possible resubmission.
In principle, it is possible to carry out the internal audit internally on your own. But consider: This has only a small depth of evidence (self-developed + self-reviewed + self-considered as good). Therefore we offer you the opportunity to do the audit with a “Certified Lead Auditor” from our network, to get direct feedback on your status. By taking this step, you significantly increase the chances of success for the admission to a CB/NB.
2. QMS – Pre-Assessment prior to final certification at Notified Body
We offer a review of the 100% completed quality management system (QMS) documentation before you carry out a certification with a Certification Body / Notified Body to save you unnecessary costs for a possible re-certification due to non-conformities.
If a “Certified Lead Auditor” from our network finds discrepancies in your documentation, you will have the opportunity to correct the non-conformities in advance.
3. Technical documentation – pre-assessment prior to CE certification at Notified Body
We offer a review of the 100% completed technical documentation before you perform a CE certification with a Notified Body in order to save you a possible re-certification due to non-conformities and the corresponding costs.
If a “Lead Technical Assessor” from our network finds discrepancies in your documentation, you will have the opportunity to adjust the non-conformities.
4. Clinical study plan – pre-assessment prior to initial contact with ethics committee
In our experience, the first contact with an ethics committee only makes sense when 75% of the study planning and 80% of the technical documentation has been completed, because otherwise no substantive, goal-oriented discussion is possible and there is correspondingly little interest in discussion.
A “Clinical Investigator”, “Medical Writer” or CRO (contract research organization) from our network will review your documents and provide direct feedback on your status.
5. Clinical study protocol – pre-assessment prior to initial contact with study center
The first contact with the study center for a clinical study, to be used, e.g. for CE certification, only makes sense when 75% of the study protocol and 50% of the study planning has been completed, because this way you evaluate the fit of the study center to your requirements, strengthen your negotiating position regarding the necessary scope and save unnecessary “nice to have” costs.
A “Clinical Investigator”, “Medical Writer” or CRO (contract research organization) from our network will review your documents and give you direct feedback on your status.
Other services for startups
To accelerate your success, we have developed the following additional services for startups. These offer you the following added value:
- Remain focused on your top priorities and have experts worry about the rest: ask for our startup packet finance, startup packet corporate design and online marketing and much more
- Find traction fast and maintain it: take advantage of periodic project review meetings, continuous due diligence, regular sparring opportunities, interims management, etc.
- Access to funding: Incubator Invest GmbH, VC and business angels network
- Team building: Mediation, professional recruiting of new team members (if required)
- Life Science specifics: Rapid Certification Programme, IP consulting, network
Startup Package - Accounting | Tax | Legal
Remain focused on your top priorities and take advantage of the service packages our partners offer exclusively to MII-startups:
- Financial accounting
- Payroll accounting
- Preparation of the opening balance sheet
- Preparation of the annual financial statements
- Business valuation
Tax support services
- Tax compliance
- Minimisation of your tax burden
- Avoidance of tax risks
- Tax declaration
- Selection of legal form
- Articles of association
- Managing director employment contract(s)
- Loan agreement(s)
- Other legal advice
We help you with our expertise, processes and tools to keep traction and stay focused. Moreover, we help to make things possible by offering you access to our network.
Our services include:
- Personal coaching, sparring and mentoring
- Help with business model development
- Continuous due diligence
- Operational project management
- Consulting on industrialization and operations management
- Access to the MII network (institutes, universities, industry)
- Access to investment capital
- Professional search for additional team members
- Interim Management
You can always approach us with your individual requests and we will find the best solution to help you.