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Pulmotree Consulting Munich is a business unit of Pulmotree

We focus on strategy and organisation management, process development, quality management and operational issues in medical technology. We are a team of specialists helping partners both in an advisory capacity and as the lead in project management.

For the pharmaceutical industry we provide advice and consultancy on medical devices and combination products. Like an efficient medicine it offers excellent chances of improvement: for processes and communications within specialist departments; for management; for making processes easier for personnel; and for sustainable increased productivity for the entire medical company.

Our consultants have wide experience of medical technology and the pharmaceutical industry. Their broad knowledge and experience are key to quickly understanding patient and customer needs and thereby creating added value to our client specialisations.

 

Medical technology and pharmaceutical consultancy services:

Project management

  • Analysing existing project management systems and developing options for optimisation
  • Implementing project management in medical technology and the pharmaceutical industry
  • Setting up appropriate organisations and structures
  • Allocating roles and responsibilities within the company
  • Drafting a project management manual
  • Supporting internal crisis management for projects
  • Undertaking projects, sub-projects and managing specific activities
  • Facilitating events such as project start workshops

Regulatory affairs

  • Developing and implementing regulatory product requirements and strategies for the pharmaceutical industry
  • Supporting 510 (k) submissions
  • Implementing CE certifications
  • General product approvals and approvals of medical devices and combined medical products

Quality management

  • Developing and implementing quality management systems (QMS) in life science companies
  • Qualification of suppliers
  • Carrying out internal and external audits
  • Adapting QM systems to comply with the new Medical Device Regulation (MDR)
  • Advising on FDA requirements, e.g. 21 CFR 820
  • Implementing ISO 13485:2016 certifications
  • Analysing existing QM systems and internal processes
  • Performing gap analyses
  • Setting up all relevant quality management processes
  • Support and advice during certification by notified bodies
  • Controlling and implementing CAPA processes

Product development

  • Using the Pulmotree Medical Network for comprehensive support from product conception to product exit
  • Drafting process instructions for product development
  • Creating documents according to FDA requirements (design control documentation)
  • Documentation in design history files (DHF)
  • Creating device master records (DMR)
  • Validating and verifying medical devices
  • Analysing and evaluating technical systems
  • Risk management according to ISO 14971
  • Biological evaluation strategy according to ISO 10993
  • Verifying the applicability of medical devices according to ISO 62366 (usability)

Change management

  • Conceiving change processes
  • Implementing change management systems
  • Implementing operational changes
  • Technical product changes

Medical technology production

  • Establishing production sites at home and abroad
  • Screening external production
  • Implementing medical technology production lines
  • Developing assembly and manufacturing processes
  • Selecting suppliers and arranging partners

Further services

  • Due diligence support
  • Strategy and pharmaceutical consultancy
  • Developing new markets in the life science sector
  • Selecting suitable medical devices for combination products (drug & device)

Start-ups in the medical
technology sector

  • Support and consultancy for medical start-ups during the foundation phase
  • Determining minimum requirements for the medical device and the company
  • Support in funding applications
  • Setting up of initial quality management systems
  • Supporting the creation of initial processes as well as holistic project management
  • Arranging contacts in the pharmaceutical and medical technology industry
CC stands for Customer Caring
Pulmotree focuses on customers. And their products.

The status quo is called “Customer Centricity”. Pulmotree takes it a big step further. Our approach: Customer Caring. To care, to listen, to be there. Transparent and dependable. With passion and integrity. The key is communications that are perfectly tailored to each project. Communications which not only get to people, but also connect them. Communications that directly produce better results. Taking the entire company forward.

The black and white of transparency
Transparency is the key to mutual trust.

Pulmotree Consulting’s transparency for the medical and pharmaceutical industries is evident in each of our projects from the first to the last step.

1. Project briefing

We start with a project briefing which we prepare in close cooperation with the client. All partners involved then get to know each other better and we get a clear understanding of the customer’s needs and surroundings.

2. White spot analysis

At the same time, we perform an initial “white spot” analysis. The results show clearly what needs to be done and what we can do to support our partners.

3. Efficient project team

To keep things together and costs down over the entire project period, project teams are individually assembled. The team provides support over the entire process lifetime.

T(3P)M

We have developed the “Transparent Partner Participated Project Management Process“, or T(3P)M, for an open and trustworthy way of working together. The core idea is to holistically involve clients in all project activities. By using software, both sides can view all tasks and activities at any time and from anywhere.