Contact: Krista Botsford
76 Northeastern Bvld, Suite 29A
Nashua, NH 03062
Phone: +1 603.589.2502
Fax: +1 781.552.9585
Email: kbots@5-Trees.com
Web: http://www.5-trees.com
World-wide environmental compliance solutions for electronics products (e.g. EU's RoHS/WEEE, CA RoHS, Korean RoHS, EU's EuP, REACH, etc.).
Services include assessments, road mapping of compliance strategies, education on directives, documentation updates and creation, as well as design, testing, and auditing services through partnerships.
5-Trees provides services locally, regionally, and nationally.
Contact: Roger Thijs
Van Frachenlaan, 89
B 1820 Steenokkerzeel
Phone: 32-2-307 8989
Fax: 32-2-307 8990
Email: roger.thijs@euro-support.be
Web: http://www.euro-support.be
Executive Interim Management
Interim management (transition management, change management) guaranties
that (re)organization proposals are realized, since the interim manager
assumes line responsibility in the client's organization during the
realization of the project.
Euro-Support, Inc. is in the market since 1996, focusing on US Companies
looking for assistance in the Benelux and in Northern France.
Focus area's are: general management, supply-chain management, operations
management and IT-project management.
Methodologies supported include brown paper analyses, lean, constraints
management, value stream...
ERP packages supported or implemented include SAP, Movex, Axapta, Oracle
Applications...
Contact: Richard K. Field
245 First Street. 18th Floor
Cambridge, Massachusetts, 02142
Phone: +1 617 444 8473
Fax: +1 617 444 8405
Email: rfield@subsidiarydevelopment.com
Web: http://www.subsidiarydevelopment.com
International Subsidiary Development Inc. provides fast, cost-efficient penetration of new markets for high-technology, software, and medical companies. As consultants or interim managers, we develop international sales, marketing programs, partnerships, distribution centers, support offices, and/or subsidiaries for our clients. Each of our business developers offer years of international business development expertise, combined with valuable knowledge of regional business cultures and resources. ISD increases your return on cross-border & cross-market investments by reducing your time-to-market, reducing your new market-entry-risk, and reducing your business development costs.
Lostraat 35
2220 Heist-op-den-Berg
Belgium
Phone: +32 (0)15 24 48 19
Email: dries@cannaerts.be
Web: http://www.cannaerts.be
As a medium sized, local CPA office, we have first hand experience in helping our clients gain access to foreign markets. Understanding the legal and regulatory environment is the key to success. Many companies pass up valuable opportunities because they fear the administrative complexities of entering a foreign market. We are well positioned to address the needs of smaller and medium sized companies that want to expand their market in Belgium.
Contact: Theo Nusselder, Director
Esdoornlaan 13
Phone: +31 343 442 524
Fax: +31 343 442 162
Email: office@cepartner4u.nl
Web: http://www.cepartner4u.nl
Your Authorized Representative and Regulatory Affairs office in EU under the Medical Device Directives.
On December 7, 2003, the CE-mark became a legal requirement for almost every medical device marketed in EU. This means that a manufacturer, who places medical devices under its name on the EU market, is responsible for meeting the requirements of the Active Impantable Device Directive (AIMD), Medical Device Directive (MDD) or In-Vitro Diagnostic Medical Device Directive (IVD). These requirements focus on quality, safety and performance.
To comply most, except class I, manufacturers need to implement a quality management program. For low risk products, the manufacturer has to perform a self-assessment to prove that the requirements of the directives are met. Medium and high-risk devices require an assessment performed by a Notified Body.
Regardless of risk classification, all manufacturers must place a technical file in EU to be available to the Competent Authorities only. Each medical device must show the name and address of the manufacturer and it’s EU Authorized Representative.
CEpartner4U simplifies the requirements that apply to your devices and provides examples of documentation through its 7-steps EU Entry Package. CEpartner4U is an independent EU Authorized Representative firm that confidentially maintains technical files covering all risk classification devices and registers Class I and IVD devices with the EU Competent Authorities.
CEpartner4U offers independent services to non-EU manufacturers who plan to CE-Mark their devices through: · Knowledgeable interaction between Competent Authorities, Notified Bodies, Distributors and end-users · Affordable consultancy that helps you build your technical file(s) with a focus on simplifying the documentation.
CEpartner4U is staffed with a team of experienced Lead Assessors and medical device researchers with offices in the Netherlands and in the USA (QNET, Minnesota). See: [http://www.ce-mark.com].
Contact: Jamie Morgan, Manager
Alexandra House
The Sweepstakes
Ballsbridge
Dublin 4, Ireland
Phone: +353 1 6641608
Fax: +353 1 6865223
Email: jamie.morgan@cirs-reach.com
Web: http://www.cirs-reach.com
Chemical Inspection & Regulation Service Limited (CIRS Ltd) is an independent service provider to help companies all through the supply chain to prepare for REACH.
CIRS has a dedicated cross-functional project team to ensure the efficient implementation of REACH and help your business in the industry navigate the REACH registration process. Besides, with extensive understanding and knowledge of the REACH legislation we will provide you rapid, confidential, comprehensive and cost-effective services to fulfil the European Union's environmental compliance requirements.
So you just do your business and let us remove the blocks in your pre-registration/registration process of REACH.
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