2020 
1BU2
1Bu2 Innovation R&D is an Engineering Office specialized in R&D, conception and projects management of Innovative Medical Devices.
Tailor-made service provider, specialized in R&D, design and project management of Innovative Medical Devices from Class I to Class III.
3D PRECISION SA is a company founded in January 2014 and located in Delémont, at the heart of Swiss Jura, region recognized for its industrial skills and in small part manufacturing (medical – watches).
3D PRECISION SA is composed of an experimented and motivated team whose skills cover all the processes from the conception help (adaptation) and additive manufacturing, including machining and finishing.
Our diversified machinery park enables us to produce parts up to 250x250x280 mm in a wide range of material and to ensure the required manufacturing and finishing from our customers.
3D-Medlab is an engineering office specialized in consulting and supporting healthcare professionals in the use of additive manufacturing.
Our activity is exclusively dedicated to the development of 3D printing in the medical field.
It mainly concerns 3 sectors:
– Industrial (manufacturers of medical devices who want to develop new product lines by additive manufacturing or who want to be supported in the development of their 3D printing activity, Technology Transfer)
– Hospital (Simulation centers, surgeons and healthcare facilities wishing to integrate additive technology into their structure: to develop anatomical models, customized cutting guides, adapted and / or disposable instruments, customized implants)
– R & D: Research and studies of new materials and 3D manufacturing processes for the development of innovative and future medical devices.
Established in Thonon-les-Bains (74) on the Geneva Lake shoreline, ALTIMET has become over the years the the leading French manufacturer of 3D non-contact surface metrology instruments. ALTIMET was able to capitalize on its experience in Swiss watchmaking and aeronautics with geometry-texture combined control specifications for complex materials and alloys and offers today a full range of standard and modular instruments adapted to the measurement of polished surfaces and textures on coated, complex, transparent material from the medical technologies. ALTIMET equips the technical centers studying the wear and the functionality of surfaces, but also the metallurgy of the alloys, the preparation of the surfaces, the plasma coating, the coldspray … this with as many applications as of types of surfaces whose method by step of development and / or finishing will require conformity checks throughout the production. AltiSurf® machines are qualified in osteosynthesis by manufacturers of orthopedic prostheses for hip, knee, shoulder, spine, but also plates, screws and pins, for which a specification of surface condition will be related to osteogenesis. The specification of roughness of the screws and inserts being moreover primordial in the practitioner’s gesture, there are many systems integrating a double rotary axis measuring. ALTIMET offers the rental of machines on site ramped-up in less than two days, in the form of training-hire-sale, as well as a service measurements on demand.
ARISTOTECH Industries is a worldwide acting contract manufacturing company of medical device outsourcing services.
We are providing expertise from design and development, engineering and product testing through finished goods manufacturing.
Our heart is the forge, surrounded by all supporting production steps till sterile packaging.
“MADE IN GERMANY” is highlighting a world class level of quality combined with an attractive pricing structure.
Belmonte a plus de 25 années d’expérience dans la fabrication d’implants. Certifié ISO 13485 nous maîtrisons nos process et avons tous les moyens de mesure 3D et de qualité de surface.
Nous nous sommes forgés un solide savoir-faire dans l’usinage des PE UHMW, Titane, Inox implantables, bases Cobalt ainsi qu’une maîtrise de toutes les spécialités du milieu médical.
Notre marché principal est celui des implants orthopédiques (hanche, genoux, épaule) mais également les implants rachis et trauma.
The company develops, produces and markets under the deconex® and decosept® brand names globally renowned products for professional applications in hospital hygiene, industry and in the life sciences sector. The company’s own centre of expertise develops and tests cleaning methods for medical institutions, manufacturers of precision parts, analytical laboratories and drug manufacturers. Borer Chemie’s portfolio features innovation, effectiveness, safety, quality and excellent value for money. At its headquarters in Zuchwil, over 160 highly specialist products are manufactured on state-of-the-art production equipment. The entire company is certified to ISO 9001 and ISO 13485. Borer Chemie AG employs around 110 people worldwide. With the support of its two subsidiaries in Shanghai and in Germany, Borer Chemie AG markets its products and services directly or via national representatives in over 67 countries worldwide. The company was founded in 1965 by Anton Borer and is entirely family-owned. Its Managing Director is Dr Markus Borer, the son of the company’s founder. Borer Chemie AG’s head office is in Switzerland.
Spécialisé dans l’usinage de précision depuis 25 ans, Céfiméca est votre partenaire pour la fabrication de vos implants et instruments orthopédiques et rachidiens.
Forte de l’expérience et du savoir-faire de ses 120 collaborateurs, l’entreprise s’appuie sur le référentiel ISO 13485 (certifiée par le LNE/G-MED depuis 2008) et la réglementation FDA 21 CFR part 820 afin de vous garantir une qualité et une traçabilité optimales.
Le parc machine dédié à l’usinage des métaux et plastiques, à la finition et au contrôle ainsi que les partenariats avec plusieurs acteurs reconnus du secteur vous permettent de n’avoir qu’un seul interlocuteur pour la réalisation de vos produits.
Active for 30 years in the medical technology area, industry application, luxury, sport and in the additive manufacturing 3D, Composites Busch is located in Porrentruy and is certified ISO 9001 and ISO 13485.
To drive into our company, follow: https://www.youtube.com/watch?v=cTMWhekMERQ
Composite materials are becoming a competitive alternative, mainly due to the following advantages:
Unique | Efficient | Approved
In an environment as advanced and competitive as medical technology, Composites Busch has always been searching for innovative and efficient solutions. Our specialists not only bring expertise in composite materials and structural engineering, but also a deep knowledge of the medical issues and requirements.
Medical standards are among the highest and medical companies, as well as surgeons and patients, need to rely on products that meet these stringent quality requirements every day. Therefore, in choosing your partner in the complex and demanding field of medical technologies, only the best will do. When Composites Busch joins forces with its customer, an eminent team is created, capable of overcoming the most challenging problems.
Whatever your expectations, we can provide the solution.
DPMR works mainly in the medical device field of activity. The main factors of its customer loyalty are the precision of the machining, the quality and the cleanliness of the devices.
DPMR is certified ISO 13485 V2003 and ISO 9001 standards internationally recognized.
The wish of DPMR is the satisfaction of its customers, while respecting these regulations. We are committed to provide the best possible service.
Our latest generation machines are equipped with digital multi-axis controls. 5-axis machining and our requirement for part finishing make DPMR a reliable partner for the realization of your medical devices.
LAM is a subcontractor leader in the industrialization and manufacturing of medical devices. We are able to provide implants and complex instruments for different medical industries : spine, knee, hip, shoulder…
Our quality requirement guarantees all our customers the best practices in terms of qualification and traceability: mastered processes (QI/QO/QP), measurement system analysis, qualified team, devices history record.
Peek is manufactured and distributed under the brand name Vestakeep since 2005, first in its industrial grade for automative and aerospace industry, then in its medical grade for instruments, provisional and long term implants …
You will find all technical, regulatory, quality, biocompatibility information and english PDF documents on the following web site (in English) :
FORECREU IS CERTIFIED ISO 13485 by BSI.
Le groupe ICARE est un groupe de dimension internationale expert dans la maîtrise de la contamination au service de la santé industrielle.
Créé il y a bientôt vingt cinq ans près de Clermont Ferrand, le groupe ICARE compte aujourd’hui une équipe pluridisciplinaire de 140 collaborateurs.
Le groupe ICARE est composé de 3 filiales françaises spécialisées : Laboratoire Icare et Icare Validation à Clermont Ferrand et MedLab à Sao Paulo au Brésil.
Avec plus de 1000 clients dans 30 pays, un chiffre d’affaire de 10 millions d’euros en 2016 et une croissance moyenne de 15% par an sur ces vingt dernières années, le groupe ICARE est un partenaire de choix pour les acteurs de la santé industrielle.
Son expertise et la fiabilité de ses prestations sont assurées par les différentes certifications, accréditations et agréments. En effet, ICARE est certifié ISO 9001 pour ce qui est de son système de management de la qualité, accréditée COFRAC pour l’ensemble des analyses microbiologiques sur les dispositifs médicaux, l’analyses des eaux, le dosage des résidus de stérilisation à l’oxyde d’éthylène et les analyses microbiologiques des surface et de l’air pour la qualification des salles propres. Tous les essais sont effectués selon les BPF (cGMP), les BPL et les exigences de la FDA. Enfin, le laboratoire Icare a obtenu le statut d’établissement pharmaceutique en 2009. ICARE est membre des comités de normalisation nationaux et internationaux (Stérilisation et Salles propres) ce qui lui donne la possibilité d’anticiper les changements règlementaires, d’avoir une bonne vision sur l’évolution des normes et d’être acteur de cette évolution.
Le Laboratoire Icare propose des prestations sur mesure pour ses clients pour leur permettre d’avoir l’assurance que les produits sont mis sur le marché en conformité avec les exigences réglementaires et normatives françaises, européennes et mondiales: biocharge, endotoxines, test de stérilité, identifications ….Les laboratoires s’étendent actuellement 3000 m² de zone classée (de ISO5 à ISO8 soit Classe A à Classe D) et une phase d’extension est prévue pour atteindre une surface totale du laboratoire 4000 m² d’ici quelques années.
Icare Validation propose une offre complète de la qualification d’équipements à la validation des procédés,en passant par l’accompagnement technique (formation et consulting). Cette offre complète inclut la réalisation des tests pris en charge par le Laboratoire ICARE. Cette filiale spécialisée du groupe ICARE est composée d’une équipe réactive et compétente de techniciens qualifiés, ingénieurs et experts techniques. Les techniciens se déplacent dans un laboratoire mobile entièrement équipé pour la prise en charge des échantillons dès le prélèvement (Incubateurs qualifiés, climatisation, géolocalisation et suivi de température en continu, groupe électrogène intégré).
is specialised in rubber molding.
The rubber compounds used meet the high specifications for pharmaceutical and medical applications like FDA and USP class 6.
Recently, INTERCARAT has developed solutions for masking of a large range of implants like cup, hip, knee and tibial components, based on FDA molded Silicon rubber masks that are very well adapted for the plasma spray coating of Titan or HAP, and for sandblasting too.
The masks are put very easily on the implants, just before the coating process.
This solution increases the security and the productivity of the masking step, by replacing the use of glassfiber strip sticking with silicone glue.
Indeed, the use of the strip has several disadvantages: firstly it needs very much time of high experimented workers, secondly there is each time the risk of contamination due to residue of the glue.
Since 1982 KKS Ultraschall AG develops, produces and markets technologically leading solutions in the fields of Industrial Cleaning, Ultrasonic Technology & Surface Refinement.
In 2003 the KKS Medical Surface Center was opened. Here we offer our entire technological and practical expertise as well as our passion for this field to a global customer base, providing advanced and comprehensive services to customers from a range of different industries. Thanks to our application-oriented research and development, we continuously acquired further know-how. In all we do we are at the cutting edge of technology – with Swiss precision.
KonMed est spécialisé dans la réalisation d’instruments radio-transparents et d’instruments tubulaires.
Ces produits présentent de bonnes propriétés : légèreté, tenue mécanique, biocompatibilité, bonne tenue à la stérilisation vapeur.
Exemples d’applications : viseurs, rétracteurs, dilatateurs, fixations externes…
Certifiés ISO13485, nous aidons nos clients pour la conception et la production de leurs instruments.
For over 40 years, the company LASER CHEVAL has designed and manufactured standard and specific laser machines which suit to customers needs (marking, traceability, identification, beam treatment, texturation, fine cutting, sealed welding)
With its range of laser sources from nanoseconds to femtoseconds and its range of catalogue machines, LASER CHEVAL has the know-how and the expertise to support the customer in his machine investment process, especially regarding black marking with resistance to oxidation on DMs and tools, texturation on implants, laser welding on chirurgical items, conception of special machines for medical applications (marking of graduation on dental bits/drills or on gaujes.
Training, software development, technical assistance are directly managed by LASER CHEVAL technicians.
The compagny is specialized for more than 40 years in the custom manufacturing of high precision surgical instruments and ancillaries for cardiology and orthopedic (cutting and drilling guides, graters, holder, reamers, spacers, drills, …..) made of stainless steel, titanium, aluminium and plastic. The company is ISO 13485 certified and FDA registred .
PRECIMETAL ORTHOPAEDICS has experience in the manufacturing of prosthesis for knees, hips, shoulder, …. These parts are delivered as raw pieces or machined following specific terms and techniques to the field.
The technical possibilities of the process allow the production of complex instruments combining lightness and resistance. The internal health of the part as well as the surface allow to achieve high standards of hygiene and sterility.
PRECIMETAL ORTHOPAEDICS offers you:
The manufacturing process by the lost wax method allows to treat your requests very strictly on:
PRECIMETAL ORTHOPAEDICS offers to the medical sector in the area of orthopaedic implants and instrumentation, techniques and competences which gives us a good reputation as premium investment casting foundry.
PRECIMETAL ORTHOPAEDICS manufactures difficult parts following your design with high technical demands in cobalt-chrome and other alloys.
PRECIMETAL ORTHOPAEDICS
PRECISION CASTINGS
Chaussée de Mons, 89
7180 Seneffe – Belgium
Tel : +32 64 52 20 00
Fax : +32 64 52 20 10
contact@precimetal.be
In year 2011 Evonik had joined all its medical activities in building a Health Care division, after buying SurModics Pharmaceuticals Inc, USA, ex Birmingham Polymers then the Resomer activity of Boehringer Ingelheim, it becames the world leader in resorbable materials for orthopaedic and traumtology implants, as well as its active pharma delivering devices, based too on lactic and glycolic acids.
The range of services offered by this non-profit organization includes material testing, advisory services, training as well as technology transfer
Testing services and advisory
The RMS Foundation offers advisory and test services to outside customers in the most various fields of application on an order basis and in line with its general business conditions.
The services of the RMS have been certified in line with the SN EN ISO 9001 standard. All tests are performed according to or in imitation of official standards. The whole range of services has been accredited according to the ISO/IEC 17025 standard. Specific tests according to the wishes of the customer and bases on RMS standard services can be done too.
The testing services in a short summary:
Incorporated in 1950 to manufacture vibrating machines for deburring and polishing, the Rollwasch company remained family owned and independent. Very reactive, modern minded, it manufacture today fully automated machines and robots … its know how is now going far further than bowls, with centrifugal barreling, disc or wave finishing !
Very concerned by the green economy, Rollwasch invented new process with less water, or totally dry, manufacturing its own media 100 % natural.
Make a free trial …
To know more (in French and other languages) : http://www.rollwasch.it/fr/products/fields/medical
Simon Medical manufactures high precision mechanical parts dedicated to the orthopaedic industry.
From prototype to series, we monitor the production of your implants and ancillary instruments (knee, hip, spine, shoulder and extremities implants).
Since 1986 we do our best to meet your requirements and make your project a reality using our expertise and high performance machines.
We follow closely the quality of the products during the whole production process and we are certified ISO 13485 by BSI (notified body).
Vapormatt are the world’s leading wet blasting company. The wet blast process is used for creating highly uniform, very clean and extremely reactive surfaces on a range of metallic and composite surfaces. Our core competence is process control giving our customers complete ownership of their surface finishing to ensure the highest levels of consistency and, most importantly, repeatability.
VBM Orthopaedic Polymers is a part of Groupe Forecreu.
