Product Development

61medical develops solutions from the clinical problem to approved medical products according to ISO standards and MDD/MDR. Our proprietary solutions or our contractual developments can be handled in work packages, going as far as 61medical acting as the legal manufacturer.

Our Concept

61medical benefits from many areas of expertise along its development process.

Our PRAGMATISIMO Workflow

At 61medical, the innovation and lean process PRAGMATISIMO™ for a new product is handled in flexible work packages that can be individually purchased and ended after each phase. R&D, manufacturing and quality engineers are involved as a cross functional team along the whole product development process.

Feasibility

Planning from an idea to a finalized prototype.

Design Input

Effective project start and user requirement definition including regulatory activities.

Design Output

Prototype verification according to predefined user requirements and design freeze.

Design Transfer

Development and production of a first device lot and zero series.

Design V&V

Validation and verification activities, device industrialization and completion of all regulatory documentation. .

Submission

Submission for CE marking to notified body.

Delivery, PMS

Product delivery and Post Market Surveillance.

About

61medical develops and produces medical devices and also acts as legal manufacturer.
As part of a global network, we have access to researchers, developers and physicians. Our clients include start-ups, clinicians, small and medium sized enterprises as well as international MedTech companies from Australia, Europe, USA and Asia.

Contact

61medical Pty Ltd
PO Box 261
Greenslopes 4120 Qld Australia
info[at]61medical[dot]com[dot]au