Development of surgical instruments which facilitate an alternative surgical technique and are compatible with existing implants and instruments.
The Customers R&D and QA/RA teams were absorbed with transition to MDR; long milestone process for getting CE certification.
Outsourcing of product development process to Effectum Medical for engineering and establishment of technical file. Effectum Medical acts as legal manufacturer. Integration into the customers QMS once the product is established in the clinical environment.
Design Engineering, Regulatory and Quality Management, Independent Reviewer
The customer’s shortage of resources was bridged, and the project was realised in a short timeframe. It took 3 months for engineering, technical documentation, manufacturing and certification.
Development of trial components which are compatible with an existing third-party arthroplasty system.
The customer had no internal engineering and no quality management system. It wasn’t economical to implement all of it for this project.
Outsourcing of engineering and quality management to Effectum Medical. Effectum Medical acts as legal manufacturer.
Design Engineering, Regulatory and Quality Management, Independent Reviewer
Product development, certification and production was realised within 6 months and the customer could apply the new surgical technique, using the new instruments, in the OR.
Development of a new product family of spinal cages and the required reusable instrumentation.
Innovator/ investor with a product idea, but without experience in medical device development and product registration.
Effectum Medical was an outsourcing partner for building a new company, developing the product portfolio, implementing a QMS, obtaining ISO certification and preparing the company for selling it to an investor.
CEO, Design Engineering, Regulatory and Quality Management
The product idea was realized with complete development and first production followed by an exit after 18 months.
