Medical Device Consulting Services
We believe the heart of healthcare is service to others
We provide Medical Device Consulting Services and are specialized in regulatory affairs and quality systems. We are specialists of global market submissions especially for Europe, US, and Canada. We are helping medical device manufacturers since 2012.
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Making sure your documentation, quality management, and testing is aligned for medical device approval experience doesn't have to be as daunting as it may seem. With our help, you not only have access to our expertise in document compliance, quality management and usability testing. You will also be working out our team of regulatory specialists, auditors, engineers and more.
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Our services are specifically designed to help you pass medical device approvals and start selling your device
LICENSING AND REGISTRATIONS
How to get FDA approval
Health Canada Medical Device Establishment License (MDEL) and Medical Device Licence (MDL)
Register as small business with Health Canada
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.
How to Get approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.
We can help you register as a "small business" to qualify for Reduced Fee and Tax Savings
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Compliance with CE marking requirements, MDR (Medical Device Regulation 2017/745
The company must prepare an extensive package for NIOSH. This includes various performance tests, drawings, packaging and label copy, detailed user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility.
COMPLIANCE AND REGULATIONS
Quality Management Systems (QMS)
ISO 13485 & ISO 9001
ISO 13485, Medical devices
– Quality management systems
– Requirements for regulatory purposes, addresses the development.
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ISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities
​ISO 9001 – Quality management systems. Medical Device Consulting Services are extended to this standard which can useful for distribution activities
MDSAP program compliance preparation, quality system upgrade, maintenance of the system, mock audits
Health Canada’s expectation as a MDEL holder is that you are following the good practices (GMP) to ensure the quality of the products you distribute. These practices are demonstrated by following procedures and completing forms associated with these procedures.
Internal and supplier audits as part of our medical device consulting services
Most companies find quality management audits and inspections stressful. Our regulatory affairs experts and lead auditors will help you to quickly pass these audits (ISO 13485, ISO 9001) and inspections (21 CFR part 820) and establish concise and customized quality management systems (QM systems)
HEALTHCARE TRASNPORTATION, WAREHOUSING AND DISTRIBUTION
From same day delivery to white glove shipping of medical equipment, we provide supply chain solutions to fit your needs
Scalable, customized healthcare logistics, environmentally controlled and cGMP compliant warehouse & distribution centers
