iPoint Blog

How The Automotive Sector Can Do MedTech

Due to COVID-19, protective masks and respiratory equipment are in high demand. iPoint Compliance can support the automotive sector in achieving cross-industry compliance with the help of digitalization.

Lack of protective masks and respiratory devices

COVID-19 is spreading fast across the globe. Supplies of urgently needed medical equipment are running short. Thankfully, a large number of automotive OEMs and suppliers around the globe are repurposing their facilities for the production of e.g. protective masks and are considering the production of fans for respiratory protective devices.

Medical devices bring different regulations

The automotive industry is already handling a large number of cross-sector regulations like REACH and sector-specific regulations like the ELV directive. But when bringing medical devices onto the market, a different set of regulatory compliance requirements has to be met (MDR, (EU) 2017/745). Considering the time pressure, the question arises of what can still be done when using existing means and methods.

With the help of digitalization

The answer lies in digitalization. Or, to be more precise, in the digitally-enabled automatization of compliance processes. A highly automated solution like the one iPoint provides supports companies to collect, analyze, manage, and report compliance-relevant data across the entire life cycle of products. It also helps mitigate risks for non-compliance, liabilities, as well as financial and reputational damages. Having relevant data at hand in a digitalized solution therefore enables to check for compliance against any kind of regulation.

Compliance across industries

At iPoint we have a long history of supporting the automotive industry in mastering their compliance challenges. The iPoint Compliance Solution e.g. allows to automatically integrate IMDS data and run compliance checks on the data. This ability of our integrated software solution to handle complex structures and their composition is paramount in making sure that whichever product that is brought onto the market complies with any kind of substance regulation that applies to this kind of product. In this respect, compliance in any industrial sector has large similarities.

Use of existing data and processes

Therefore, we are convinced that the automotive industry is sufficiently equipped to meet those challenges also in the production of parts for medical equipment. Using the tools, materials, and processes already in place, a product can be evaluated against the likes of a GADSL (Global Automotive Declarable Substance List) as easily as against, for example, the RoHS directive or a list of CMR substances, which are key when bringing medical equipment onto the market.

The iPoint Compliance Solution provides compliance checks not only for the automotive industry, but also covers key regulations for the electronics, manufacturing, medtech, and other sectors from the discrete manufacturing industry.

Angelika Steinbrecher

Add comment