EXCO provided legally compliant support to a security technology manufacturer in addressing new challenges in medical technology and the market placement of a SARS-CoV-2 rapid test.
Although an exceptional authorization for near-patient laboratory diagnostics under Section 11 of the German Medical Devices Act (MPG), without a fully completed conformity assessment procedure, would have been possible due to the epidemic situation, this route was not pursued. Instead, a complete technical documentation package was created within a very short timeframe. As part of this effort, EXCO prepared the required manufacturing documentation in STED format for submission to the Notified Body.
A particular challenge was that no GMP requirements had previously been applied to the manufacturing process.
EXCO Services
- Regulatory Affairs consulting
- Product development: design verification
- Manufacturing: process validation and equipment qualification
- Computer system validation (CSV) in accordance with Annex 11 of the EU GMP Guidelines
- Medical device approval support
Customer Benefits
- Integrated disciplines
Development of the product and provisioning process coordinated as a single project. Optimized for project timelines while ensuring regulatory compliance. - Audit-ready compliance
The technical documentation for the customer's new product variant is compliant and meets the approval requirements for an in vitro diagnostic medical device in accordance with Directive 98/79/EC. - Faster time to market
Despite significant time constraints, collaboration with EXCO enabled results to be achieved more quickly.
Customer
A leading manufacturer of industrial security technology
