Our MDR gap assessment tool is our basic version. This tool contains complete MDR with all chapters (1 - 10) and appendices (1-17).
Regulatory Globe develops strategies and digital tools to provide regulatory affairs expertise to medical device startups, as well as small and mid-sized companies.
Its mission is to meet the increasing demands of medical device regulation and laws without deploying expensive resources.
Based in Switzerland, the company’s highly qualified regulatory affairs specialists in the medical device field can offer necessary regulatory expertise to businesses across Europe.
Regulatory Globe offers its expertise in two main ways – as a consultant or in the form of digital tools.
The company’s digital tools offer a cost-effective solution in enabling clients to guide themselves through medical device regulation issues.
Regulatory intelligence papers and tools for MDR, IDVR and MDSAP
Regulatory Globe’s Intelligence Paper fully cover the fundamental points of laws and regulations in the USA, Canada, Australia, Brazil, Japan, Europe, UK and Switzerland and focus on ISO 13485 2016, Medical Device Single Audit Programme (MDSAP), medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).
Regulatory Globe tools allow users to implement all relevant topics into their company in a simple process.
The tools enable users to get a better understanding of MDSAP, MDR or IVDR, supporting clients in evaluating and implementing all relevant requirements.
MDR and IVDR gap-assessment services
Regulatory Globe compiles an MDR and IVDR gap-assessment based on clients’ process landscape and products. Customers will receive a complete assessment report with all internal gaps marked as high, middle, and low risks, as well as an implementation plan to expedite projects and it enable users to speed up their project immediately.
Permanent regulatory support
MDR Article 15 requires manufacturers to have available within their organisation at least one person, internal or external with permanent access, responsible for regulatory compliance, with the necessary knowledge in the field of medical devices.
Regulatory Globe’s services and tools bring the necessary knowledge to companies to meet these requirements.
Company tailed regulatory intelligence support
Regulatory Globe collects all the crucial requirements and regulations based on individual business specifications. The company also compresses them so clients can assess within several seconds whether they are relevant to their company or not.
This process saves clients valuable time with tedious research and documentation.
Smartphone app for EU documentation
Regulatory Globe’s smartphone app provides information on new published EU MDR documents. It also offers complete EU MDR and IVDR implementation guides.
The app is suitable for all who work in the medical device industry, particularly those in the quality and regulatory affairs fields.
With the available newsletter, clients can remain informed about upcoming news and changes regarding EU MDR and IVDR.
EU authorised representation
Regulatory Globe partners with EU authorised representative EUmediq.
The two entities jointly offer full packages from the first requirement to EU market access.
You do not have the time or resources to prepare a gap-assessment over your company and products? No problem. We are Regulatory Affairs experts and can provide you with a full assessment of your company and products within three weeks.
For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union.
A signed mutual recognition agreement (MRA) between the EU and Switzerland by 26 May 2021 does not seem conceivable anymore. This means Switzerland will become a third-party country where Swiss manufacturers need an EU-authorised representative to export their products into the EU.