Development, series transition and production are not the only areas that speak for a technology partnership with WILD. The Austrian company also makes an important contribution on the path to product approval, helping to bring customer products to market safely and quickly.

Regulatory affairs require manufacturers in the medical technology sector to pay the utmost attention and constantly update their knowledge. This is costly and time-consuming. As a system partner, the WILD Group therefore feels responsible for supporting its customers in the area of product approval. The necessary know-how – from requirement management to FMEA and process validation – is covered in-house and in the partner network. “If the approval process is taken into account right from the start and WILD is brought on board as a partner, the approval of medical technology products is faster and easier,” emphasizes Managing Director Wolfgang Warum.

WILD has been specializing in the demanding requirements of medical technology for decades. Not only in terms of product development and manufacturing, but also with regard to the entire approval process, in which WILD sees itself as a sustainable partner. For example, in addition to EN 13485 certification, the system partner demonstrates GMP-compliant manufacturing according to FDA specifications. And the list of fascinating products that WILD produces and that have already been successfully approved on the market is long: Whether novel laboratory analysis devices, surgical equipment, innovative illumination systems for endoscopic procedures, therapy devices or high-performance medical lasers – wherever precision, reliability, speed and the implementation of innovative findings are required, the system partner can play to its strengths. The foundation for this is broad know-how and the combination of the areas of development, quality management, process development and project management. “We pass this knowledge on to our customers as a development and production support service that can be relied on right from the start,” explains WILD Systems Engineer Melanie Täuber.

Stable step to faster approval

For CTO Wolfgang Warum, this is a crucial point. “Regulatory affairs are not at the end of a product development process, but start with the product idea. Those who bring experience and knowledge in regulatory affairs start from a much more favorable position. At WILD, we see it as our job to accompany our customers in this process.”

Their wishes and requirements are already documented in the concept phase, taking into account the regulatory framework, and checked for feasibility. The system partner provides support, among other things, in the form of a compilation of the product file, which is simplified thanks to integration into the document management system (DPMS). To keep development time as short as possible, WILD uses its many years of experience and extensive solution expertise.

Quality assurance at every stage of the product life cycle

“However, we see one of our greatest strengths in the flexibility we offer. Because we have implemented stable development, production and quality assurance processes, both complete new development and support in sub-areas are possible,” knows Melanie Täuber. The requirements vary depending on the customer. Therefore, WILD development works with two variants. The first is the development process, in which the customer approaches the system partner with a product idea and is supported until the transition to series production. On the other hand, there is the compact development process, in which the customer receives support, for example, in the construction or design of individual components of a complete system.  Individual work packages are then offered here. And then there is the case in which development has already been fully completed and the customer needs an industrialization partner and producer. “For all these routes to market entry, we offer a professional solution. After all, series transition can also be a process, for example in the case of changes to the product, in which our comprehensive approval know-how plays an important role,” says Photonic Systems Engineer Mikael Erkkilä. The same applies to further developments in the product lifecycle, for which WILD also provides regulatory support. “Since everything is done from a single source, we can also act as quickly as possible in this phase.”