Competences – From consulting to approval
Our success as one of the world’s leading OEM manufacturers of components for minimally invasive medicine is based on the special competences and unique expertise we have acquired over decades. In addition to a high-quality basic range, we provide the entire process from initial consultation to the declaration of conformity and the approval of products and components individually tailored to the respective requirements.
Consulting
Do you have a very precise idea of your guide wire or nitinol basket that is tailored individually to your requirements? Do you wish to receive any suggestions from an EPflex expert? In any case, we will advise you.
Development
We provide the complete process from the initial planning of the project up to the declaration of conformity.
FEASIBILITY
- Project planning
- Requirements specification and functional specification
- Researching standards
- Risk management
- Profitability
PROTOTYPES
- Product design
- Packaging
- Sterilisation
- Prototyping
- Pilot production
APPROVAL
- CE certificate in accordance with Regulation (EU) 2017/745
POST MARKET
- Market surveillance
Production Expertise
Specially trained personnel, state-of-the-art production facilities and ISO class 8 clean rooms: We produce high-tech instruments at the highest quality level.
In-house fixture and special machine construction
Raw material stock
Wide choice of coil material: Coated, Uncoated, Nitinol, Stainless Steel
Cutting to length and deburring
Deburring of cut edges with control under camera system – over 60,000 wire cuttings per day!
Burr free cutting
Electrochemical “Everite” cutting saw
Vibratory grinding (trowalizing)
Special process for surface treatment: deburring, rounding, polishing, matting
Sandblasting
Roughening and deburring of wire sections in 3 fully automatic sandblasting machines
Flat pressing
Increase of pliability without loss of tensile strength
Grinding
Our core competence – 46 grinding machines with automated loaders and 6 CNC grinding machines for special grinding contours
Centerless grinding
For cylindrical or conical contours up to Ø min. 0.09 mm
Plunge grinding
Grinding of special profiles up to Ø min. 0.1 mm
CNC grinding
Grinding up to Ø min. 0.05 mm e.g. for PTCA wires
Fully automatic testing
Checking diameter and necking 100%
Forming nitinol wires
Twisting of wire components, thermal forming and special shapes
Stainless steel wire forming
Manual or semi-automatic forming of wire ends, e.g. eyelets
Form J tip
Manual or semi-automatic application of various tip shapes
Springs wrap over stylet
Sample production of special springs – the illustration shows a spring made of three different materials
Elongation of springs
Spring elongation in defined range
Laser welding
Welding of metallic components, e.g. baskets or rounding of stilettos – over 20 laser workstations
Plasma welding
Creation of a semicircular welded joint between core and spring – 19 plasma welding workstations available
Gluing
Creation of an gluing bond between spring and core wire – 23 Semi-automatic bonding systems
Gluing proximal
Attachment of a transition between spring and core on particularly thin or sensitive components
Marking
Electrochemical marking of stainless steel surfaces (oxidation process)
Laser marking
Applying markings with the use of a laser
Laboratory
Organic and physical chemistry laboratory
Passivating
Improvement of the corrosion resistance through chemical modification of the surfaces
Dip coating
Application of hydrophilic plastic coatings
Shrinking and rounding
PTFE hoses are shrunk on to guide wires and rounded off
Pebax tips
Attaching Pebax tips to pre-ground core wires
Cleaning
Parts are cleaned using appropriate methods (e.g. ultrasound) and selected cleaning cycles (cleaning, flushing, drying, while taking temperature and time into the account)
In-process control
Fully automatic tensile test 100% – Optical measuring method up to 1000x magnification
Dispenser
Clipped and welded variants
Sealing
Packaging medical products by sealing them in sterile pouches
Packaging and Sterilisisation
We guarantee safe and sterile packaging for all EPflex products and we will respond exactly to your wishes and ideas.
Regulatory Affairs
We support you in the approval of your medical products developed in cooperation with us and you can buy from us products manufactured and ready-certified according to your requirements.
QUALITY MANAGEMENT
Our quality management system complies with the requirements of the ISO 13485 standard.
We are a member of the German Institute for Standarisation e.V.
GUIDELINES
Regarding our guidewires (Class IIa and Class III) and stone retrieval devices (Class Is), our quality management system complies with the requirements of Regulation (EU) 2017/745
Our class III guidewires are designed in accordance with the requirements of Regulation (EU) 2017/745.
OTHER REQUIREMENTS
We were also able to prove in corresponding audits that we fulfil the following requirements:
- 21 CFR 820 (USA)
- RDC No. 16 (Brazilian GMP)
- MHLW Ministerial Ordinance 169 (Japan)
- Korea GMP
• • Taiwan GMP
Your Contact Person
Dr. Johannes Uihlein
Managing Director
T +49 7123 9784-0
