Our Expertise
GlobalMark offers numerous services for the following Business Lines:
Medical, Hazardous Locations, Industrial, Energy, Lighting, Appliances, Laboratory
Design Review
GlobalMark's consulting experts will provide guidance for complying with the relevant safety and performance standards. We can advise and guide you through specific construction and testing requirements, provide product design guidance and assist with documentation preparation.
GlobalMark can provide Consulting Services that can include, but are not limited to the following:
•Provide Strategies on the design that will best fit your global implementation of your product as required by International and regional standards.
•Devise Test plans for certification compliance, manufacturing and production lines, and design change.
•Develop and oversee information required in design history files and design controls, such as: FMEA's, identify hazards, severities, probabilities, design and process mitigations, verification and validation protocols, and residual risk.
•Required documentation and labeling
•Generate isolation diagrams
•Component qualification and selection
Project Management
GlobalMark’s consulting experts will provide guidance for complying with the relevant safety and performance standards.
•Advise and guide you through specific construction and testing requirements, provide product design guidance and assist with documentation preparation.
•Perform preliminary testing and review components and subsystems against the requirements.
•Develop a response strategy to address any non-compliances or findings issued by a certification agency
Machinery Directive
GlobalMark's consulting experts will provide consultation/design review services on your product line to evaluate the equipment versus the applicable CE requirements including the Machinery Directive and to the standards there under such as; EN60204-1, EN ISO 12100, EN ISO 13849-1, EN ISO 13849-2, EN 62061, EN ISO 13857, EN ISO 13854, EN ISO 4413 and EN ISO 4414 as applicable.
GlobalMark can provide Consulting Services that can include, but are not limited to the following:
•Technical reviews of device design, technology, engineering drawings, performance, safety, or usability.
•Red-lining/commentary on risk management processes, quality manual, or product risk assessment
•Development of a risk management file/process
•Guidance in completing your product risk assessment
•Provide training on the differences and similarities of US and European standards requirements
•Help in identifying gaps, where your products do not comply with the various standards, and provide in depth explanation of the standard's requirements
•Help in reviewing design options for compliance with the applicable standards for risk and safety
Medical Consulting
Our Services
•Preliminary Design Review & Guidance
for complying with relevant standards
•FDA 510(k) & Technical Construction File Support
•Global Market Access & Country Research
•Staff Education & Training Sessions
•Risk Management File Guidance
The Benefits
•Leverage our standards expertise
•Minimize regulatory delays
•Minimize testing failures and costly re-designs
•Get to more markets faster
•Reduce FDA clearance time
Technical Files
GlobalMark’s consulting experts will provide guidance and assistance to develop a Technical File such as:
•This will cover the essential requirements, contents, claims and marketing (if applicable), classification of products according to level of risk, identification of applicable laws and directives required on the EC Declaration of Conformity.
•We will work with the applicable team representatives in your company to review your documentation used to support the Technical File.
•We will identify gaps in your files and documentation and also help you understand the requirements for importing a product into the EU.
•We will then work with your team to review options for compliance where gaps or deficiencies exist. Should this be CE
Hazardous Locations
GlobalMark’s Hazardous Locations consulting experts can advise and guide you through specific construction and testing requirements, help you select your protection methods, provide product design guidance and assist with documentation preparation.
Global Mark will provide Consulting Services that can include, but are not limited to the following:
• Identification of viable protection methods as they relate to markets desired for your given product type.
• Hazardous Locations certification requirements for Canada and the United States markets.
• Product design guidance to achieve compliance with the relevant standards including constructional and testing requirements.
• Component selection with consideration given towards the end product compliance to relevant standards.
Our consultants will work with the appropriate representatives in your company to review your product and documentation with the goal to identify the best path forward to achieve compliance for your product(s).