Case
Validation expertise helps medtech company scale up production
Producing safe, user-friendly and high-quality medical device products requires validation at every step of the process. As Swedish medtech BOHUS scales up its production and development of new products, Semcon is supporting the company with strategic validation expertise.
CustomerBOHUS
IndustryLife Science
CompetencesMedtechValidationProduction DevelopmentQuality Management
Background
BOHUS manufactures premium medical device products based on hyaluronic acid and specialises in three disciplines - ophthalmology, aesthetics and orthopaedics. With production set for expansion, Semcon has been tasked with reviewing its efficiency while securing quality at every level.
Henrik Angeldal is a validation expert at Semcon and has previously worked with a number of prominent companies in the pharmaceutical and medtech industry. He now supports BOHUS with everything from efficiency processes and requirement specifications for new equipment to deviation management and authority inspections.
"My job is to ensure that the right processes and routines are developed, complied with and that everyone works according to the routines while, at the same time, quality is built into the design of equipment and systems. It involves everything to ensure that the manufactured products are as safe as possible and go to market as fast as possible," Henrik says.
From research to finished product
In addition to boosting the production of existing products, BOHUS is also developing new products.
In the role of validation expert, I also oversee how new products can be manufactured in the most efficient way. This is about scaling up from the research stage to production, which involves long processes and lead times with various authorities before products can reach the market.
- Henrik Angeldal,validation expert at Semcon
Long experience in life science
Semcon has extensive experience of supporting companies in every part of the process when bringing medical device products to market and is familiar with the issues that arise along the way.
For BOHUS, Semcon supports with:
Ensuring consumer safety throughout the process and product lifecycle by defining requirements and integrating quality into equipment and system design.
Knowledge and experience in deviation management, change management and authority inspections
Serve as a liaison between the quality and production departments, balancing regulatory compliance with manufacturing costs and production rates.
About BOHUS
BOHUS develops and manufactures premium medical device products based on hyaluronic acid and specialises in three disciplines – ophthalmology, aesthetics and orthopaedics.
