At the end of 2020, Examec signed an agreement with one of Sweden’s largest players in brain surgery based on gamma rays.
The agreement was for the rapid start-up of continuous manufacturing and assembly of complete, tested and ready-to-deliver machines for cancer surgery in the human brain using gamma rays. The start-up period from signing the contract to the complete delivery of machine No. 1 was agreed to 17 calendar weeks, which thus also included the Christmas and New Year holidays 2020.
The realization of the agreement naturally included process descriptions with their respective FMEA analyses and development of processes in many different areas such as ultrasound examination, measurement, processing, tools, assembly and test methods, with associated training and documentation for subcontractors and own staff, etc. etc.
In parallel, some twenty fixtures were developed, constructed and built for both machining and assembly and investments were made in 15 and 20 ton pallets and the purchase of a truck for 25 tons of cargo.
A second parallel track was the updating and implementation of the management system according to ISO 13485 (medical technology) as well as certification, before the first machine delivery. In order to verify, audits by the validation body KIWA followed and of both management systems and product audits on the part of the customer.
The third parallel track included work on improvements to the product together with the customer’s design and quality departments with the accompanying ECO (Engineering Change Order) at machine six, which was challenging for traceability reasons, among other things.
This has been the company’s most extensive investment, not so much in material terms as in terms of organizational development, training, and team building.
The result has been a fantastic success that has lifted the entire company and our customer relationship to a whole new level.
Each delivery have been made on the right day and just before the upcoming holidays, unit No 10 will be boarding the truck and on its was to the client.
It has been a tough but fantastic year from all of us at Examec with accomplishments that have created a whole new situation for us.
Now we all look forward to a quiet period of rest over the holidays and promise to return with refreshed power to take on new projects and continue our positive development.
We wish our clients and contacts Merry Christmas and a Happy New Year!
For more information, don’t hesitate to contact our proud CEO, Mats Ohlsson, phone +46 708 45 05 67