Healthcare Quality and Regulatory Services
Providing a Complete Suite of Quality and Regulatory Solutions
Changing regulations and increased scrutiny of product conformity has taken new dimensions in the medical device sector taking world markets to more innovative solutions and challenging product designs.
Strategic and efficient Solutions​
for easier market access
Device Quality Systems
Increasing regulatory demands globally have pushed device manufacturers to comply global markets.
​
-
QSR (21 CFR Part §820)
-
ISO 13485 (through 2016 transition)
-
CMDCAS
-
TGA
-
PMDA / JPAL (MHLW)
​
Whether your product is a active or non-active medical device, device in itself or combination of devices, procedure/sterile packs, or a standard medical device, In-vitro medical device, implant device or drug-device combination we offer comprehensive solution for managing your product technical library so as to extract product technical documentation in accordance to the needs of the market like DHF, DMR, TF, TCF, 'Seihin Hyojun Sho' (Japan Medical Device Technical File) or other.
In accordance to the needs of the complexity and risk classification of the product further parts of this technical documentations may include integrated file system components employed during verification and validation (like Risk Management File, Trial Master File, Technovigilance reports, etc.,.)
Regulatory Management
Placing a device in the market involve collating and designing a flawless regulatory submissions for the regulatory agencies requiring mindful approach for product scenario and manufacturing processes.
We support your product submissions:
-
European CE Marking
-
US FDA 510K / PMA / IDE submissions
-
CMDCAS/HC device licences, and
-
Kyoka(Licence) with Ninsho, Todokede, Shonin for PMDA/JPAL, and for other territories
through our secure (SFTP) docket management platform.
Placing a product into a market require to satisfy regulatory requirements for both manufacturing process and/or product conformances. As FDA require facility registration and compliance to 21 CFR Part §820 in USA and so in EU manufacturers need to comply to directives (MDD / IVDD / AIMDD).
We support building your quality system to comply the requirements through process documentation, process validation / revalidation, measurement and monitoring systems and provide 'state of art' consultation in specific and applicable standards including variations in compliance to territories.
Auditing and consultations
We have a experienced fleet of medical device auditors and assessors simultaneously consulting with EU's well known notified bodies. Bringing their valuable experience from manufacturing industry we assure to provide cost effective and efficient auditing solutions including variations for your supply chain needs and scenarios.
Internal audits are mandatory controls (§8.2.2 of ISO 13485). Nevertheless, auditing is a significant tool for continous improvement of the quality systems within any organisation. No matter if they are internal or second party audits (internal audits and supplier audits according to ISO19011 practices), Or third party or regulatory mock audits (according to ISO17021 practices) the audit scope and criteria shall have to identify the respective industry standards. As like, ISO13485 for medical device industry or ISO9001 as in PQMS (pharmaceutical quality management system).
Our experienced auditors assist identifying these requirements in your system and provide knowledge base on consultation basis tailor made for your needs*.
​
*All costs involved in each audit project include the audit report under the agreed turn around with the auditor.
2. Online Project Schedules
3. Quicker Consultant Support
1. Dedicated Client Support
Helping you find the right QA/RA solutions.
At Elixir Medicals Ltd. we specialise in various product technologies in medical device industry and we support process and product validations, quality and regulatory doket management.
