Healthy advice

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

  • Implementation of project management
  • Analysis and optimization of the existing project management system
  • Project management manual
  • Project crises mediation
  • (Interim) take-over of projects, sub-projects and individual activities
  • Moderation of conferences, workshops, team events

Regulatory affairs

  • Regulatory requirements and strategies
  • Classification determination of the device or combination product
  • Communication with competent authorities and certification / notified bodies
  • Submissions (e.g. CE Technical File, 510(k))
  • Support through the consultation process (combination products)
  • Risk Management (ISO 14971)
  • Biological Evaluation (ISO 10993-1)
  • Usability (ISO 62366)
  • Technical File compilation (MDR, FDA)


Quality management

  • Gap Assessment
  • Implementation of a quality management system (QMS)
  • Fulfillment of requirements per ISO 13485 and 21 CFR 820
  • Supplier qualification
  • Conducting Audits (internal and external)
  • Setting up relevant processes and supporting the implementation
  • Change management

Product development

  • Comprehensive support from product idea to exit via Pulmotree Network
  • Technical support of R&D
  • Design Control documentation and related procedures
  • Design History Files (DHF)
  • Device Master Records (DMR)
  • Validation and verification

Medical Writing

  • Clinical Evaluations (MDR, MEDDEV 2.7.1 rev.4, various MDCGs)
  • Medical Review (by product specialists, physicians, caregivers)


  • Selection and qualification of suppliers
  • Setting up production sites or production lines
  • Development of manufacturing processes

Business Support

  • Interim Management
  • Due Diligence
  • Device Monitoring (e.g. for entering new markets)
  • Selection of suitable medical devices for combination products (Drug & Device)
  • Strategic and regulatory roadmap
  • Notified Body selection
  • Referral of partners

Support for start-ups

  • 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.


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.