Medical Technology

Industry challenges and use cases for a successful digital transformation

A good medical technology product is created by taking into account a combination of medically reasonable, (IT) technically feasible and statutory requirements. The MDR/IVDR restructuring in particular requires development and documentation experience, which many manufacturers have yet to build up. Engineering sciences, IT, organisation and quality management must work together to make prudent entrepreneurial decisions that ensure the continued existence of existing products on the market and help to open up new business areas.
The development and operation of complex networked medical technology requires a wide range of know-how and a view of the whole. Especially the integration of medical devices into the complex laboratory IT infrastructure requires many years of professional and IT experience.
Here, PTA offers exceptional competence in the combination of technical expertise and economic sense of proportion in consulting and implementation, which allows manufacturers to focus on the product vision and to operate successfully in the long term.


Challenging and constantly changing regulatory environment

Critical functions for patient health, user safety and privacy

Engineering knowledge and IT expertise required

Integration of new products into complex processes and quasi-standard environments

Long development cycles with high innovation pressure

Solution approaches

Holistic approach: product, integration, processes and organisation

Support across life cycles, combined with a high proportion of skilled workers from the relevant disciplines

Synergies from different industries flow into the concepts

>15 years (250 person years) experience in regulated software development (ISO/EN 62304, 62366)

Synergies from different industries flow into the concepts

Own ISO 13485 certified QM system

Use Cases

Long-term development partner for LIS systems – a highly integrative task

Laboratory information systems are the hub and integration platform for all technical processes in the laboratory. They integrate a variety of medical devices and processes and thus allow efficient interaction within the laboratory and with the system landscape of the clinic or laboratory community. PTA’s own special combination of technical and IT expertise enables a world market leader to outsource the product development of its internationally distributed products.
From technical specifications to design, development, quality assurance, roll-out and 3rd level support, PTA covers much more than the classic software development process. The integration of instruments into laboratory workflows is taken into account through close cooperation as early as the development phase of the devices, interfaces are defined at an early stage and the efficient implementation of new device functions in the integrated laboratory environment is made considerably easier through early expansion of IT. This makes us one of the few IT service providers with comprehensive laboratory IT competence in Germany for more than 15 years.

Professional, technical and methodical competence in laboratory IT

All-in service for LIS (further) development

Exceptionally long experience in regulated SW development according to ISO/EN 62304

Development experience on the equipment, LIS and integration side

Top priority of the development team on product quality

Efficient integration through cooperation between equipment development and IT

Comprehensive outsourcing to partners with product focus and quality awareness

New certification strategy and SW development according to PTA ISO 13485 certified QMS enables further operation according to MDR (Medical Device Regulation)

An established patient data management system (PDMS) is subject to new criteria for approval due to the amendment of the MDR. A diagnosis- and therapy-critical functionality of the current PDMS is not sufficiently developed and documented after the re-evaluation. By creating a certification strategy and redeveloping the critical component using the PTA’s quality management system certified according to ISO 13485, a declaration of conformity can be issued that ensures continued operation as a medical device.

Certification strategy

SW development according to PTA QMS

Declaration of conformity

IT Medical Device Development & Certification

New approval of medical devices – evaluation of the documentation and comprehensive support for revision and implementation of the specifications

Established manufacturers of medical devices such as suction pumps, obstetrical equipment and infusion pumps must re-approve their products under the new EU Medical Device Directive MDR (EU 2017/745). After an assessment of the existing documentation by the PTA, gaps in risk management acts, requirements, specification, verification and validation documentation will be identified and closed according to an agreed procedure. The PTA provides support in documentation, but also in verification and the establishment of a document management system.

New approval according to MDR (EU 2017/745)

Evaluation of risk management according to ISO/EN 14971

Gap analysis documentation according to ISO/EN 13485 and ISO/EN 62304

Review process

Close documentation gaps

Implementation of verification tests (software and hardware)

Documentation strategy and implementation from one source

Etablierung agiles Vorgehensmodell

Systems Engineering – Transformation of a start-up into a productive organisation at an equipment manufacturer

A good idea is turned into a product by a highly qualified team from a wide range of disciplines working together effectively and flexibly. This is how prototypes and first routine samples of a device are created, which integrates hardware, software and AI components.

As the product becomes more professional, organisational units such as sales, R&D, production and support must be created that work together efficiently – a transformation process takes place. The PTA advises on this and additionally supports the implementation through practical collaboration, e.g. as Product Owner and Scrum Master.

Operational Assessment

Pragmatic solutions

Monitoring of the implementation

Cooperation in configuration management, interface design, project and programme management, QA, risk analysis, software development

Systems Engineering

Organisational transformation

IT medical devices development consulting

A component manufacturer for medical devices is expanding its portfolio with a new, complex medical device. During the development of the new device software, PTA is available as a discussion partner for architecture and design decisions.


Medical device-Software

Reflection of design decisions

Have we aroused your interest?

Dr. Thomas Steinmann

Dr. Thomas Steinmann

Bereichsverantwortlicher Life Science

  • LinkedIn

  • Xing