Our success is based on the fact that with our know-how we can bring new, innovative medical products more rapidly and successfully to the market.

 

Today, short time-to-market times are particularly important since the market is very competitive and these projects are primarily capital driven.

 

Whether a product receives approval one year sooner or later is critical! In this way we provide our customers with important strategic and competitive advantages.

 

Straight forward development at your finger tips

epmodex is your design- and development specialist. Our wealth of experience in a diverse array of demanding industry applications enables us to integrate a wide range of technologies quickly, competently and economically. Using a combination of creative and systematic methods, we offer you tremendous innovation along with optimum process reliability and very high standards of documentation.

Our services:

// Patent research and -Application
// Product development
// Industrialization, Design- Transfer
// Systems engineering
// Product life cycle management
// Assembling- and manufacturing technology
// Product risk management according to ISO 14971:2012
// Quality engineering
// Verification-, validation-, qualification activities
// MDR- remediation
// UDI & Traceability
// Product labelling & Packaging
// Product regulation according to EU Medical Device Directive 93/42 EWG/ Medical Device Regulation 2017/745 and US FDA 21CFR820

We provide expertise in the following medical markets:

// Dental
// Traumatology
// Orthopaedics
// Spine
// Surgical innovative instruments
// Combination products

Since May 26th 2017, when the new European Medical Device Regulation (MDR – directive EU 2017/745 & IVDR – directive EU 2017/746) has been established all medical device suppliers are working under high pressure to implement these standards to assess the conformity of their products. 

On May 26th 2021, the Medical Device Regulation will become fully applicable, following the transition period. Hence, all processes related to design, industrialization, manufacturing, marketing and market surveillance have to be aligned with the quality management system which must be compatible with ISO 13485:2016 and/or USA QSR.

We help you to get there- Due to our top-level expertise and a wealth of experience we advise and support our global customers in updating and correcting their technical documentation. With this service we ensure to successfully accelerate procedures along the entire life cycle of medical devices to keep the products safe. Our clients know that we fully adhere to their industrial standards and that we stand for personal assistance, fast response times, on time delivery and the highest level of flexibility.

Keen to see how you get your products MDR compliant in 7 steps?

In less than six months - on May 26, 2021 - the European Medical Device Regulation (MDR) will come into force. On the very same day, the corresponding Swiss Medical Device Regulation (MepV) will enter into force. If the agreement between Switzerland and the EU is not updated by the MDR's applicability date (May 26, 2021), EU manufacturers will have to comply with specific Swiss requirements per Medical Device Ordinance from the start. This includes the appointment of a Swiss AR for all medical devices imported into Switzerland.

epmodex as your new Swiss AR will help you to continue your growth in selling your products in Switzerland- after May 2021. Use our wealth of experience and challenge our top- level service!

Keen to learn more?

epmodex is your systems realization partner

Systems Engineering is the key when merging different technologies together. Or further, on security-relevant missions that cannot be examined on the basis of a prototype run. Systems Engineering is an established standard- not only in the medical device industry. It is firmly anchored in projects and in the organization. Without the holistic and systematic approach and the consistent use of methods and processes of systems engineering there's no guarantee for a successful project implementation as "first time right". 

We ensure that the result meets the requirements, and in the first attempt and at the right time. The methodology is established where complex interrelationships prevail or where safety-critical aspects have an impact and human lives are in danger. Nothing is left to chance and may go wrong with the introduction. Therefore, Systems Engineering has been used in our projects for years.

We offer precisely interlinked and modular services for complex products associated with very small error tolerances, high standards of documentation and very detailed change management– all in accordance with ISO 9001 and ISO 13485.

Thanks to our team of qualified experts, our clients benefit from technical expertise in all areas of product realization and product life cycle management. We can guarantee quality, short lead times and punctual delivery thanks to our comprehensive expertise and end-to-end processes – as a one-stop shop.

Accuracy- The key for success

It is one thing to develop products and bring them to the market but another to provide superior quality in a standardized serial production that you can count on. Quality assurance comes first priority at epmodex!

We continually develop and optimize our business organization to rest assured that you can fully rely on our quality- today, tomorrow and in the future.

We measure precision

One of our key steps is the precise measurement in all sectors and models. In order to avoid even the smallest errors we use high-end measuring equipment and- methods for dimension control (e.g. 3D- Measurement Machines CMM, CT-Scanners, etc.) conducted by our carefully selected qualified operators.

Test equipment management - It's no coincidence

Properly functioning testing equipment for quality monitoring is essential, as this is the basis of any quality assurance.
The ISO 13485 framework for the manufacture of medical technology products obliges our customers to apply CAPA measures (Corrective and Preventive Actions), to guarantee traceability and change control throughout, to implement risk management that conforms to standards, and to make consistent use of training and document management. In order to meet these numerous requirements, a management system is needed that guarantees complete documentation and comprehensive monitoring and enables rapid, cross-departmental responses to changes of all kinds.
For this purpose, we use a powerful software in production that supports the management of test equipment, test equipment capability studies and the calibration of test equipment. From simple calipers to the most complex, multidimensional measuring equipment, from dial gauges to specialized and process-integrated in-house developments. We thus guarantee for an integrated test equipment management at the highest level.

We care just like: Trust is fine, control is essential!

Knowhow and expertise are the base for our client satisfaction. Here is a selection of our valuable client base.