"Regulatory-Software/Software-Regulatory": Metecon-DigiLab interprets for RA digitization -- COMPAMED Trade Fair


Metecon GmbH

"Regulatory-Software/Software-Regulatory": Metecon-DigiLab interprets for RA digitization

Metecon's new DigiLab brings medical device manufacturers and RA software providers together: DigiLab translates manufacturers' regulatory requirements into vendors' technical solutions. Since 2019, the DigiLab team has tested 30 softwares at its own expense and thus objectively. DigiLab's ever-growing software selection ensures that the individual best software for the medical technology manufacturer is quickly found. This shortlist is then tested with all stakeholders and implemented after a successful trial run.

There are enough good RA software solutions, but the demand for them is still low. The reason: the providers of software tools for regulatory affairs do not understand the complex requirements of medical device manufacturers, and the RA managers on the manufacturer side do not have in-depth IT knowledge. The result: communication problems and the uneasy feeling on the manufacturer's side that a large project is on shaky ground from the start. So they put digitization on the back burner.

A bad decision, according to Metecon CEO Alexander Fink: "The digitization of RA has to come. The error rate of previous Excel and Word solutions is high, capacities in the departments are lacking, and personnel bottlenecks will continue to exacerbate the situation in the future: There is no other solution in the medium term than to digitize regulatory affairs workflows."

At DigiLab, Heike Krüger is responsible for selecting the appropriate software providers and supporting and moderating the selection and implementation process. She knows the decisive advantages of DigiLab compared to the self-initiated search for suitable software by the companies themselves: "My team and I have been in dialog with the software manufacturers for two years. We have seen 30 demo versions and put relevant solutions through their paces. What company would invest in this effort in advance for research purposes alone?"

The objectivity of the DigiLab when advising and working with customers is very important to Heike Krüger: there are no liabilities whatsoever between the software vendors and Metecon; the tools that made it into the DigiLab were tested objectively, i.e. with a deliberate waiver of commissions in the case of brokerage. Thus, she and her team are completely independent in their recommendations.

Since DigiLab customers can save themselves the market analysis, they start directly with the DigiLab team into the three phases of software implementation of digitized RA solutions:

  1. Pre-selection of relevant software tools based on the manufacturer's needs (short list);
  2. Moderated selection process in the Metecon DigiLab:
    Software configuration is tested under realistic conditions, workflows are developed, processes are run through: All stakeholders - RA and IT departments as well as employees of different country groups - are given a computer workstation in the real Mannheim DigiLab. Based on the prior analysis of specific company processes, DigiLab customers test the configuration of the software for their respective roles;
  3. Trial operation and subsequent implementation:
    Trial operation continues at computer workstations in the DigiLab or directly in the company. For the implementation, the DigiLab team develops an individual procedure strategy and implements it together with the software provider of choice for the customer (the medical device manufacturer).
For Alexander Fink, the advantages of the DigiLab are obvious: "Imagine being able to significantly reduce the time and capacity required for your digitization project. After implementing your software tools, you will not only reduce the number of errors, optimize costs and finally have all information available regardless of location thanks to digitized RA processes, but you will also be able to accelerate approval for your product and simplify market monitoring: So what's stopping you from finally starting to digitize?"

Heike Krüger and her DigiLab team are continually expanding their range of services: for example, there is now also a selection of PMS software for database searches, literature searches and editing, surveys, PMPF, PMCF; the next additions will be risk management and QM software.

Your contact persons for questions about DigiLab

Heike Krüger
Head of DigiLab
T +49 621 123469-047

Alexander Fink
Founder and Managing Director
T +49 621 123469-11

Metecon GmbH
Q7 21
68161 Mannheim
T +49 621 123469-00

Company description Metecon GmbH

Metecon advises and supports manufacturers of medical devices and in-vitro diagnostics in the documentation and approval as well as in the inspection and testing of their products. To this end, the Mannheim-based company accompanies its customers through their entire development process with all necessary complementary services from the areas of technical documentation, verification and validation, medical software, clinical affairs, quality management and regulatory affairs.

Metecon DigiLab extends and completes Metecon GmbH's range of services by supporting manufacturers of medical devices and IVDs in the selection and implementation of suitable software tools for Regulatory Affairs.

Metecon employs 50 permanent staff at its Mannheim site, all of them medical technology engineers or scientists. 50% of all management positions are held by women. The company reinvests 2% of its turnover in the further training of its employees. In 2018, the company installed an in-house academy for the comprehensive training and further education of its own team, where, among other things, new recruits are fully trained as regulatory affairs managers in a six-week full-time trainee program.

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