Representatives

Australia

in Representatives

RQSolutions

1F/1 FRANCIS ROAD, ARTARMON NSW 2064, AUSTRALIA

REPRESENTATIVE NAME: George Azoury
E-MAIL: georgea@rqsolutions.com.au
WEBSITE: www.rqsolutions.com.au
TEL: 0061.413.578.665
MOBILE: 0061.2.9413.2850
FAX: 0061.2.9413.2852

RQSolutions has over 25 years of experience in product registrations and quality management within the healthcare industry. Working closely with the Australian Therapeutic Goods Administration and other local industries, they specialize in first time product registration and ongoing compliance. Services from RQSolutions include:

  • Registrations
  • Quality compliance
  • Document management
  • Medical device directives
  • Regulatory intelligence, training and up-skilling

Brazil

in Representatives

EG Mont Brazil

RUA MODESTO JUNGUEIRA 186, 14076-120 RIBEIRÃO PRETO-SP- BRASIL

REPRESENTATIVE NAME: Eduardo Monteiro
E-MAIL: eduardo@egmont.com.br
WEBSITE: www.egmont.com.br
TEL: 0055.16.3969.5154
MOBILE: 0055.16.9961.2003
FAX: 0055.16.3969.5154

EG Mont specializes in market regulation for medical devices and electrical products. Their services cover the entire journey and include advice and guidance throughout the production process (pre, during and post) as well as:

  • Pre-shipment
  • Factory audits
  • Lab testing
  • Product component inspections

Canada

in Representatives

PASB Technical Solutions

6 BERRIGAN PLACE, ST. JOHN’S, NL A1B 1Z9, CANADA

REPRESENTATIVE NAME: Paul Bassler
E-MAIL: paul.bassler@pasb.ca
WEBSITE: www.pasb.ca
MOBILE: 001.709.699.6113

PASB Technical Solutions Inc. (PASB) provides forward-thinking mechanical, manufacturing, and process engineering as well as regulatory compliance consulting services. They work closely with clients to maximize success on operational, technological, and compliance projects. Services from PASB include:

  • Medical Device Quality Assurance
  • Regulatory Affairs
  • Machine Safety
  • CE Marking

China

in Representatives

AccuService 


8/F, Weiting Science and Innovation Park, Weizheng Road No.8
SIP Suzhou, Jiangsu, China

REPRESENTATIVE NAME: Sabrina Yu,
Elvis Zhao
E-MAIL:
sabrina_yu@accu-inspection.com,
elvis_zhao@accu-inspection.com
WEBSITE: www.accu-group.com
TEL: 0086.0512.8227.2260
FAX: 0086.0512.6805.6420

AccuService is a quality control management service that bridges the gap between international companies and manufacturers. With over 1000 employees in more than 30 service centers spread throughout China, Malyasia, Singapore and Southeast Asia, AccuService offer a range of services including:

  • Component inspections
  • Pre and post production inspections
  • Shipment supervision

Egypt

in Representatives

Ietqan

1 EL-NASR ST, NEW NOZHA, CAIRO, EGYPT

REPRESENTATIVE NAME: Hany El-Debeky
E-MAIL: Heldebeky@ietqan.com
WEBSITE: www.ietqan.com
TEL: 00202.262.161.74
MOBILE: 00201.068.843.664
FAX: 00202.262.161.74

Ietqan is a consultancy company with an encyclopaedic knowledge of medical device directives and the medical industry as a whole. With over 15 years of experience in handling blood lines, dialyzers, surgical dressings and a range of other medical products, Ietgan offer a variety of CE mark services, including CE compliance, consultation and training. Other services include:

  • Management system preparation
  • Technical file preparation
  • ETO sterilization validation
  • Clean room validation

India

in Representatives

Unikal Consultants

F/6 GOYAL PLAZA, JUDGES BUNGALOW ROAD, VASTRAPUR, AHMEDABAD 380015, INDIA

REPRESENTATIVE NAME: Sanjay Y. Shah
E-MAIL: sanjay@unikalindia.com
WEBSITE: www.unikalindia.com
TEL: 0091.79.66.090.225
MOBILE: 0091.982.401.7850

Unikal Consultants have a wealth of regulatory experience with regards to CE marking, particularly for chemical and medical technologies and products. They have been helping clients for over a quarter of a century and their services include:

  • Management systems
  • CE certification
  • Technical file preparation
  • Audits and document management
  • ISO 9000 & Quality
  • ISO 13485

Korea

in Representatives

CHEMRON FDA

#506, YOUNGCHANG B/D, 663 SEOLLEUNG-RO, GANGNAM-GU, 135-830 SEOUL, KOREA

REPRESENTATIVE NAME: Joo Ahn
E-MAIL: gracejschem@hotmail.com
WEBSITE: www.dfda.co.kr
TEL: 0082.2.568.7744
MOBILE: 0082.10.5713.3060

Chemron provide services regarding the certification and testing of cosmetic products, medical devices, foods and consumer goods. Their services include:

  • Ingredient analysis
  • Testing guidance
  • Conformity assessments
  • Clinical investigations

Malaysia – Indonesia – Vietnam

in Representatives

KM Loi

NO 27-3, JALAN USJ 9/5 Q, SUBANG BUSINESS CENTRE, 47620 UEP SUBANG JAYA, SELANGOR DARUL EHSAN, MALAYSIA

REPRESENTATIVE NAME: Dr. KM Loi
E-MAIL: khengmin@gmail.com, kmloi57@kmloi.com
WEBSITE: www.kmloi.com
TEL: 0060.12.303.6757

KM Loi & Associates Sdn. Bhd offer expert consultancy and advisory services for manufacturers. They provide efficient, practical business solutions and services for a range of Quality Assurance Directives, including:

ISO 9001:2008; SA8000:2008; ISO/TS 16949:2002; ISO 15189:2003; ISO 13485:2003; ISO 14001:2004; ISO 22000:2005; ISO/IEC 17025:2005; OHSAS 18001:2007; MS 1500:2004; MS 1722:2005; MS 1900:2005


Mexico

in Representatives

DISPOMED

AVE. División del norte 2723 PH Col. San Lucas Del. Coyoacán. CP. 04030 México DF

REPRESENTATIVE NAME: Francisco Olivares
E-MAIL: folivares@dispomed.mx
WEBSITE: www.dispomed.mx
TEL: 0052.55.5549.5961
MOBILE: 0052.1.552.095.0882

Dispomad has over 20 years of experience in quality assurance and health regulations, particularly within the pharmaceutical industry. Dispomad specialize in CE marking and medical device directives for Europe. Their services include:

  • Quality systems implementation under the Schemes of Good Manufacturing Practices (COFEPRIS), Good Manufacturing Practices (FDA), RDC No. 59 ANVISA (BRAZIL), ANMAT (ARGENTINA), ISO 9001, ISO 13485, CE MARKING and European Medical Directives (EUROPE) and other Health Systems and Regulation both Nationally and Internationally.
  • Quality system audits
  • Training in quality systems and health regulations
  • Medical device distribution
  • Preparation of Documents for Specialized Translations
  • Documentation Preparation of Dossiers for Class I, II or III (COFEPRIS, FDA), I, IIa, IIb and III (European Scheme), I, II, III and IV (Canada and Brazil)
  • Medical Devices Distribution in Mexico

Pakistan

in Representatives

R. Plus Unique Systems

Syed Raza Ullah Shah
16 First Floor Sethi Plaza Sialkot, Pakistan

REPRESENTATIVE NAME: Raza Shah
E-MAIL: razashah801@gmail.com
TEL: 0092.300.616.4428

R. Plus Unique Systems boast a team of experts across a range of fields and offer consultancy services for a variety of quality management system standards and CE marking. Their services include:

  • Good Manufacturing Practice (GMP)
  • Code of conduct audits
  • Pre-shipment inspection services
  • CE marking
  • ISO 9001
  • ISO 13485
  • ISO 14001
  • ISO 22000
  • SA 8000
  • OHSAS-18001
  • HACCP
  • GMP

Taiwan

in Representatives

LC & P Limited

2/F, No. 392, Road Xinyi Dist, Taipei City 11050, TAIWAN

REPRESENTATIVE NAME: Eric Leung
E-MAIL: eric@lcpartner.hk
WEBSITE: www.lcpartner.hk
TEL: 0092.300.616.4428

Established by 2 regulatory veterans from Underwriters Laboratories, Veecare and LCP provide a holistic range of regulatory and compliance services for global medical manufacturers. Their team members are seasoned compliance experts who worked for major notified bodies and multinationals.

VEECARE focuses on:

  • pre-submission regulatory support (risk analysis, design consulting, process validation, safety)
  • performance testing
  • quality system set-up.

LCP specializes in:

  • country access
  • market representation

YOUR CONSULTANT ON EU REGULATIONS