The medical device industry is undergoing considerable growth and change as new technologies come into use, increasing regulations and the tightening of definitions for products that bring in more products into the scope of medical device regulations.
Couple these aspects with increasing global competition and the desire to deliver medical devices compliant to global standards and there is an increasing need for independent, flexible, experts support to guide manufacturers to take the best route to compliance, to speed up time to market and keep costs as low as possible.
What we offer ...
We provide complete medical device regulatory services with unparalleled customer service without breaking your budget.
To maximize the benefits of our services, we would ideally work with medical device and IVD companies who manufacture and design Class I and Class II (IIa/IIb) medical devices and independent testing laboratories who wish to utilize our 60601 expertise on a contract basis.
In addition, to minimize associated expenses, most of our services can be performed remotely via email, telephone and other online methods. We offer a wide range of services to fit your budget and schedule:
Webinars & Training:
Customized training or webinar based on your level of experience and can be offered on an individual basis or as a group.
We can assist in preparing your clinical documents (clinical review, clinical trial) in accordance with applicable MEDDEV guidance documents.
Pre-Compliance Design Review:
Ideal for early and pre-certification compliance review. We can assess your current design against 60601 2nd and 60601 3rd editions. At the end of our review, you will receive a comprehensive report detailing the non-conformances. But, we don't stop there...we will also provide cost-effective compliance design recommendations to meet the applicable 60601 requirements.
Coordinate Formal Certification with Agencies/Regulatory Bodies:
We have established a strong relationship with major Nationally Recognized Testing Laboratories (NRTLs) and Notified Bodies that can work to your advantage in terms of potential compliance cost reduction and expedited certification services. In addition, our prior experience working directly with major Agencies will provide inside know-how on their processes. We can assemble the relevant documentation needed to efficiently certify your products and expediently coordinate the whole certification process with your chosen agency.
Risk Management File Review (RMF):
There are approximately 85 references from 60601 3rd edition that point to your product RMF. We can assess the documentation GAPs and provide recommendations on document creation and process generation in accordance with ISO 14971.
Compliance Design Inputs Throughout Product Development:
It is important that 60601 requirements are integrated as early as possible throughout product development. The idea is, once it's all said and done, is to have a compliant product prior to submitting for certification. We can work directly with your design teams and provide inputs from 60601.
Assist with FTA, FMEA, DFMECA, and other risk analysis tools to address risks called-out in 60601 3rd edition.
If you are start-up medical manufacturer, we can assist on creating ISO 13485 procedures from the ground up.
As required by IEC 60601-1 3rd Edition and the MDD, we can assist you with risk assessment.
We also provide expertise in the Machinery Directive. Some medical devices may also fall under the scope of the Machinery Directive. Ensure that all applicable EU Directives are applied.
EU WEEE, RoHS2 and REACH Directives Assistance
Submit your request now
Provided training to Malaysian IVD and MD companies on FDA & MDD/IVDD:
Active Devices Team during my tenure with BSI (UK-Training) as a Product Expert & Scheme Manager:
Hands-on experience in medical & laboratory equipment
IEC 60601 Series
USFDA Guidance and Support
We'll walk you through it
Take the guesswork out and avoid costly mistakes!
#IEC60601 #ISO 13485 #ISO14971 #MDD #particular60601 #collateral60601 #FDA 510K #FDA PMA #MDD #CEMarking #Class I #ClassIIa #ClassIIb #riskassessment #riskanalysis #qualitymanagementsystem #compliance #medica devicedirective #machinerydirective #REACH #RoHS #lowvoltagedirective #93/42/EEC #QMS