Em um mercado que rapidamente muda e no ambiente das regulamentações das indústrias de dispositivos médicos e elétricos, a capacidade de adaptação ao mercado é a chave para o sucesso. Desde o início da concepção do produto, do design, certificações, treinamentos até a exportação e a representação internacional a jornada pode ser desafiadora e cara.

Services Include:

• Pre-production
• During Production
• Post-Production
• Pre-Shipment
• Factory Audit
• Laboratory Testing
• Component Inspections

MCSI is a leader in the world of Canadian regulatory affairs for the Medical Device, Pharmaceutical, Biotechnology, Food and Cosmetic industries. Our skilled and knowledgeable associates specialise in regulatory strategic planning, organising and planning Health Canada meetings, preparing and filing Class II, III, and IV Medical Device License applications, Drug Submissions — DINA’s, CTA’s, ND’s, support during Health Canada reviews, label and advertising reviews, regulatory and compliance issues, and quality system audits (QS-GMP-ISO). Furthermore, McCarthy Consultant Services Inc. will act as a legal agent for those Drug companies that do not have offices in Canada.

Services Include:

• Regulatory strategic planning
• Organize and manage TPD meetings
• Prepare and file CTA’s (Clinical Trial Applications)
• Prepare and file Class II, III and IV applications
• Application support during TPD review
• Quality System audits (QS - GMP - ISO - CMDCAS)
• Label and advertising review
• Regulatory compliance issues

China Osmunda Medical Devices Consulting Co., Ltd. (Guangzhou, Shenzhen, Suzhou, Wuhan, Xiamen) is engaged in medical device quality management system certification consulting and medical devices registration. We dedicate to providing international medical device registration (China, the United States, European Union, Canada, Japan, Australia), medical device system certification (ISO13485, QSR820, GMP, GSP), compliance and productivity audits.   
 
We can provide a full range of solutions to medical device companies from product design, clinical trials, product testing, clean room design to business registration, products international registration. At present, we have helped nearly 200 domestic and foreign companies get a variety of medical device certification.

中国奥咨达医疗器械咨询有限公司（广州、深圳、苏州、武汉、厦门）是从事医疗器械质量管理体系认证咨询和医疗器械产品注册的专业咨询公司，致力于为医疗器械企业提供国际医疗器械注册（中国、美国、欧盟、加拿大、日本、澳大利亚）、医疗器械体系认证（ISO13485、QSR820、GMP、GSP）、对医疗器械供应商进行第二方/第三方审核和医疗器械出口验货。
   
我们能为医疗器械企业提供从产品工艺设计、临床试验、产品测试、洁净厂房设计到企业注册、产品国际注册的全方位的解决方案。目前，我们已帮助近200家国内外企业通过各种医疗器械认证。

IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help service our European and Asian clients with a variety of services for clinical, regulatory and quality system requirements including pre-clinical safety, biocompatibility and microbiological testing. The array of services encompass clinical research, planning, administration, analysis, and management of clinical and non-clinical studies; regulatory product submissions/dossiers for product approvals; quality systems (GMP/QSR/ISO) audit, analysis and design; design assurance and control; pre-production technology transfer and validation; compliance crisis management, including FDA inspection issues, FDA Warning Letters, detention, injunctions, and consent decree requirements; and, training programs for both regulatory and quality systems.

Our collaboration with certain highly qualified and cost effective European based consulting firms to provide service as a required Authorized Representative affords our clients the opportunity to utilize IRC services along with that of the Authorized Representative to help ensure compliance with CE Mark requirements.  Our affiliation with Vector Resources L.C. in the U.S. enables IRC to help clients find critical path solutions to their marketing, sales and partnering needs.

CRO SERVICES

Clinical Trial Management
• Study Design
• Study Site Selection
• Regulatory Submission/Approval
• Study Initiation
• Monitoring
• Data Acquisition/Analysis
• Biostatistics
• Regulatory Reporting

REGULATORY SERVICES
• Strategic Planning from Design to Market
• Premarket Notification 510(k) Submissions
• Premarket Approval Applications
• Investigational Device Exemptions
• EU MDD / IVDMD Compliance
• Complaint System
• Mandatory Medical Device Reporting
• Master File (DMF) Preparation and Submissions
• Labeling and Advertising Review
• mport/Export Approvals
• FDA Representation/Official Correspondent
• Compliance Crisis Management

QUALITY SYSTEMS SERVICES
• US Quality Systems / Good Manufacturing Practices
• ISO/ EN Standards
• Verification and Validation
• FDA Inspection Coordination
• Vendor Audits

U.S. AGENT/OFFICIAL CORRESPONDENT SERVICES
• Medical Device Reporting Complaint Handling Management
• Coordination with US Importer/Distributor
• Annual Facility Registration & Listings
• QSR / GMP & Regulatory Systems Analysis/Auditing
• 510(k) / PMA / IDE Submissions
• NDA / ANDA / IND Submissions
• Clinical Trial Management
• FDA Inspection Coordination
• Strategic and Regulatory Planning
• Personnel Training

TRAINING AND EDUCATION SERVICES
• Regulatory Administration
• US Quality Systems Administration (cGMP)
• Complaint Handling Systems
• Document Control / Design Control Practices
• Regulatory Submissions

Unikal Consultants, based in Ahmedabad, India, is a leading consulting and integrated service provider with over 25 years of regulatory experience to its corporate clients. The success of Unikal Consultants can be accredited to its dedicated, highly qualified, and widely experienced team in the field of CE Marking, ISO Quality Management System implementation, auditing documentation, WHO GMP Certifications, and chemical and medical technology consulting.

Services Include:

• ISO 9000 & Quality
• ISO 13485
• Management System
• CE Certification
• Technical File Preparation
• Selection of Certifying Body
• Audit, Documentation and GMP
• Technology & Know-How

KM Loi & Associates Sdn. Bhd. (669057-A) is recognized as a leading management system standard expert in management consultancy and technical advisory services for both manufacturing and services and its related supply chain.  This is accomplished by empowering individuals, teams, and organizations to achieve their goals for personnel and corporate success through effective, efficient, competitive, and practical business solutions.  KM Loi & Associates acts as Obelis’ representative for Malaysia, Indonesia, Vietnam and the Philippines.

KM Loi & Associates provide services for the following Quality Assurance Directives:
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

Ietqan for consultancy is company working in the field of consultation with core competence of the medical devices industry. Ietqan team has a collective experience of more than 20 years in the field. We are offering among other systems ISO 9001, ISO 14001, OHSAS 18001 and ISO 13485 and MDD 93/42/EEC (i.e. CE-Mark) consultation and training.

The core competence of Ietqan is Medical Devices Industry. Ietqan partners has been working in most prestigious manufacturing companies specialized in Blood Lines, Dialyzers, Surgical Dressings production for a period over 15 years. Hence the technical expertise and hands on experience is integrated part of Ietqan. We are offering much service for the medical devices industry. We are offering ISO 13485 and CE-Mark consultation and training. Also we are offering, validation services for clean rooms, ETO sterilization units, and Biological Indicator Incubation Time Reduction and aeration areas. Sterilization cycle optimization to reduce time, gas consumption also part of what we offer.

Ietqan for consultancy is ISO 9001:2008 and ISO 13485:2003. The scope of the certificates cover the validation services, hence we are the first company in the region offers those services under certified ISO 13485:2003 system
We offer:
• Management system preparation.
• Technical file preparation “CE Mark”
• ETO sterilization validation.
• Clean room validation.

Qualitech international is an Egyptian based leading consulting firm; The only specialized consulting firm in Egypt in the field of Medical Device and In vitro-diagnostic device IVDD; it has an immense reference in the Medical field in MENA region; recently; Qualitech is now knocking the door to have its own testing facility for IN-VIVO and IN-VITRO [ex. Biocompatibility, microbiology testing; product and process performance Qualification].

In parallel to the role being played by Qualitech to assist local manufacturer to launch their products internationally; Qualitech is playing an indispensible role to assist foreign products to freely market their products in Egypt, meanwhile as a short term plan Qualitech is paving the road to have the same dual services in Jordan and Saudi Arabia and Morocco; consequently to other middle east and north Africa region MENA; these services are; but not limited to the following:-

- Translating label and advertising material into Arabic.
- Act as authorized representative in Egypt.
- Handle legal and regulatory affairs with MOH.
- Registration of Medical and Para-medical product.
- Support OEM & OBL agreements.
- International support for potential business in Egypt; including Feasibility studies.
- All-in-one service provider for interested parties planning for business in MENA region specifically Egypt.

Qualitech is registered as a service provider in the Industrial modernization centered IMC; our reference # is Q10011.

Qualitech is registered as a service provider in the Skill Development Project

Qualitech is registered as a service provider in the industrial training center ITC

We are proud of being a training consultant to the Egyptian Ministry of Health; specifically the Centeral administration of pharamceutical affairs

CERMET Asia Ltd. was founded in 2003 as Korean branch of Italian certification body, and keeps our position as a foreign certification body which leads Korean certification system through registering management systems to Korea Accredited Board. Furthermore, we provide products certification service for Korean customers as having experts who are professional and have a lot of experiences. The domestic service related to authorize medical devices is also provided to overseas firms that intend export medical devices to Korean market. 

Service of CERMET Asia Ltd.:
CE Mark(MDD, LIFT, MD, PED, TPED, CPD, MID, PPE, TOY, NOISE, LVD, EMC, etc) –
ISO 9001, ISO 14001, ISO 13485, TS 16949, etc –
KFDA(Korea Food & Drug Agency) Registration –
CCC – 

CQC assists on certifying goods exported to Russia. CQC works jointly with Timesert in Russia for all regulatory and testing services. Their main focus is consultation about the product certification for exporting to the following countries: Russia, Belarus, Kazakhstan and Ukraine.

CQC and Timesert Services:
Regulatory Services
Certificate of Conformity
Sanitary-Epidemiological Conclusion
Declaration of Conformity
Designing of the Specifications
Specification’s Registration
Designing of the Technical Passports (Manuals)
Medical Devices Registration
Exemption letters for customs (VNIIS)
Exemption letters for commerce
Fire certificate and declarations
Quality Management Systems Certification
(ISO 9000, 14000, 18000)
Integrated management System
Entry permit documents for radio electronic devices
ROSTECHNADZOR Permit

Testing Services:
CQC and Timesert offer various testing services including; Laboratory testing, Certification testing, Inspection testing, Periodical testing, Definitive testing, Acceptance testing, Qualification testing, Comparing testing, Environmental testing of wet strength, humidity, cold and head resistance, cold and heat stability, Mechanical testing of vibration resistance and strength, Low Atmospheric pressure testing, IP testing, Electro Safety Testing, and Electromagnetic Compatibility Testing,

SPADE Consultancy Pte Ltd is setup to provide Speedy, Precise, Accurate, Dynamic and Excellent testing and certification services to clients who need rapid market penetration for their new electronic Products.

SPADE is your partner to worldwide approval campaigns covering more than 120 countries all over the world. Products include Medical Equipment, Information Technology Equipment, Audio Video, Household Equipment and an array of wired / wireless technologies like (Mobile (2G/3G), WiMAX™, WLAN (802.11a/b/g/n), Bluetooth®, DECT, RFID, SRD and PSTN. Apart from this, we also offer consultancy services for Solar Panel Inverters, Automotive Part, Maritime Part, Avionics Part, Railway System, Scientific Equipment and Explosive Equipment.

SPADE can provide audit services for ISO 13485 and ISO 13980.

Services Include:

• Product Compliance Services, which include consultancy in Testing, Certification and Inspection Services for 120 countries
• Product labeling, packaging and user guide localization services
• Trademark/ Patent services
• Local representative Services
• Technical Training/ Seminars
• Research Services

Excel is a full-service provider of registration, clinical research, biometrics, and training and consultation services. Excel is the leading CRO in China. With more than 350 staff members, operations in 20 cities in the Asia Pacific region, and experience working with over 120 of the world’s leading pharmaceutical and biotech companies, Excel has the resources, connections, and expertise needed to help you with your drug development needs in Asia.

We have succeeded in obtaining over 260 registration approvals/import licenses from the State Food and Drug Administration (SFDA) in China, and that number continues to grow. We initiate 70-80 new Clinical Trial Approvals (CTAs) or license applications per year. Our ability to provide the decisive technical solutions that deliver product licenses is the reason why nearly all of the world’s top 20 pharmas have chosen Excel as their registration services provider in China.

Services provided by Excel:

• Regulatory Affairs in China – Registration for pharmaceuticals, medical devices and IVDs, and healthcare and cosmetics products
• Clinical Studies in China – Study design, study management and site management, study monitoring, and medical writing
• Biometrics – Sample size estimation, drug repackaging, database creation and management, ICH-GCP compliance, and much more
• Quality Assurance – Internal and external quality assurance activities
• Others – Survey/feasibility research, training, CRA and CRC outsourcing, and consultation

Symbiotic Research Pty Ltd. combines two established contract service providers, Delpharm Consultants Pty Ltd. and Innovation Dynamics Pty Ltd.  Together, the partners offer a full range of Regulatory and Business Development Services to the medical device, pharmaceutical, agro-veterinary and biotechnology industries, including clinical trials and registration for Australia and New Zealand. 

Mediclever manages end-to-end reimbursement projects for medical device companies, selling their products in the US and Europe.
We identify availability of existing reimbursement codes, relevant for our client’s products, and in case such existing mechanisms do not exist, we outline processes and criteria for obtaining coverage, including the development of new or modified codes and the establishment of favorable coverage guidelines for such codes.
Mediclever appoints for each client an Outsourced Reimbursement Project Manager, who leads the reimbursement project and relieves our client from hiring and/or training a full-time reimbursement manager.

Mediclever can help you:

• Minimize invested resources: Avoid hiring an internal reimbursement manager. Keep your team focused on the company’s core business.
• Maximize potential: Let our experts, who have done this before, leverage their knowledge and experience once again for your company.
• Shorten Time to Market: Avoid the long learning curve, or even worse, the usual mistakes that take place when not working with an expert. Use our experience to get your products reimbursed sooner.

Advanced Compliance Engineering Services (ACES) helps manufacturers and exporters to comply with global market regulations. Through many years of experience, ACES has developed a complete understanding of both technical and commercial regulatory environments enabling them to provide manufacturers the correct regulatory tests and certificates with the confidence of working with a European Notified Body. ACES’ operational philosophy is to offer quality service and ‘value for money’ to its clients.
Services Include:

• Regulatory Affairs Services
• Internationally Recognized Testing and Certification Service
• Global Market Access Solutions and Distribution

QualityWorks Consultancy Corp. provides management consultancy and training services relating to global international standards like Quality Management Systems, Healthcare, Information Security, Health and Safety.

Services Include:

• Joint Commission International Accreditation standards requirements
• PhilHealth Benchbook
• Quality Management Systems
• Information Security Management Systems
• Environmental Management Systems
• Occupational Health and Safety Systems
• Medical Devices regulatory requirements
• European representation

AccuService is a quality control management service that bridges the gap between international companies and manufacturers. We will immerse ourselves in your China operations and strategically manage your supply chain to ensure that you receive the most cost-efficient, opportune, high quality, and stress-free experience.

AccuService maintains over 1,000 employees based in more than 30 service centers, labs, and offices around mainland China, Malaysia, Singapore, and Southeast Asia. Our services range from initial component inspections and pre-post production inspections, to shipment supervision throughout the entire supply chain process.

Superb Quality Services Co., Ltd. is a dynamic consulting firm conducting consulting and training on ISO 9000, 14000, 22000, ISO/TS16949, OHSAS 18001, BRC, GMP, HACCP, CE Marking for medical devices and various kinds of products, management skills development, Total Quality Management, Gamba Kaizen, 5S and several other training courses such as inventory control, business negotiation techniques and more.

Services Include:

• Project management
• Advice on regulatory affairs in Australia and New Zealand
• Regulatory affairs including EU, FDA, CSA, TGA
• Manufacturing feasibility and sourcing
• Clinical trial management to GCP standards
• Product registration and negotiation with regulators
• Business development and commercialization

MDC Associates is committed to working closely with clients, providing affordable and effective market research and regulatory consulting services with over 30 years of combined experience in both the medical device market and the regulatory environment.  MDC offers a unique combination of services that help clients develop successful marketing strategies.
Services Include:

• Register company with FDA
• Prepare facility and documentation required for FDA, QSR, cGMP and ISO 13485 compliance
• Monitor quality systems for continual regulatory compliance
• Develop and conduct regulatory training programs
• Prepare pre-market submissions
• Conduct facility audits
• Conduct clinical trials
• Develop clinical trial protocols