Once Your Device Acquire & Provide Patient Information, It's Already Inside of Hospital's Policy of Protection. How Would You Adopt ?
Recent dramatic IT progress in AI, Machine Learning, etc. are expediting revolutionary medicine and medical devices. Of course, the competition is getting severer.
Especially many of recent medical devices are using outside data, storage means Cloud systems and your customers may hesitate to introduce and connect to hospital network. To proof your products' safety and compliance to each country's regulation, it may be necessary to introduce out side resources to fasten your business. GDPR, HIPAA, Japanese Privacy protection Act and Health Information Promotion of Secondary Use Act, etc ... Global Companies have to check these regulations. It's very hard, but not constant job.
We can help you in these challenging area, including standard regulatory and clinical data collection and analysis cases, with the specialty in each field and using connection with past collaborators, doctors, Medical IT specialists to keep your products met to customers, patients requirements.
Also, we started to provide comprehensive representative services for medical device companies aiming to get into Japanese market in the partnership with each field's expert. Earnest Job Link Ltd. and we, AHIL lead this efforts and take role of the front for inquiries. Please use contact sheet at our front page.
Security & Compliance Systems Support for Medical Devices Designers/Developers
- It is strictly required to apply cutting-edge information technology for development of competitive medical devices with high level privacy control
- We are supporting such developers with very high motivation with keeping your businesses meeting to complicated laws and guidelines to maintain products' safety from any view point, patients, doctors and co-medicals. This work is done by the certified auditor for ISO27001 who experienced in medical device, medical image management and healthcare informatics. This should be done in the collaboration with IT security and Anti-Cybercrime forums depending on your demands and job volumes.
- We will recommend to positively use outside & cloud security testing tools to keep screening pattern and vulnerability information updated, of course after applying appropriate measurements for outside connections.
Regulatory, Clinical Research and Insurance Reimbursement Supports for Medical Devices and Pharmaceutical Products
- The communication with PMDA and MHLW take long time and is required quick response with plenty of data for early products application to the market.
- We support mainly in data collection and analysis using many sort of tools, not limited to clinical-dedicated ones and support you respond rapidly to the requirements.
QMS Certification Processes, Organization and documentations by Quality Assessment and Audits
- Our specialists have long experiences of audit and internal process analysis/improvement in ISO9001, Lean Six Sigma and ISO13485, and support your licensing and manufacturing process inspection.
IT Life Cycle Support
- Even development of medical devices, you may have to tackle to the demands of software life cycle shortening for meeting your customers' business situation and needs as far as your products contain software. The maturity of internal information infrastructure and tight partnership with hardware development dept are the key for your success.
- We dedicatedly support your business leveraging experiences of IT infrastructure managements for your quick product launch into the market.