Fine tuned advice and execution based on proven methodologies!
Pre and Post Market compliances
We bring your Medical Device, Implants, Software (SaMD), DDx, DTx, combination, wearable, and IVD products to the market and keep it there, by advising on “go to market strategy” & drafting documents needed for 510(k) clearances, DeNovo, PMA approval, CE Marking, ISO 13485, MDR compliance & more. Elexes offers an end-to-end solution for companies in the field of:
- Regulatory for national & international approvals
- Quality for certifications and audits
- Clinical for CERs and studies
- Product for DHF and risk assessments
What we offer
Regulatory
Regulatory approvals are mandatory to legally sell. Elexes has helped companies expand their businesses by partnering with them to execute end to end approval and clearance processes. Some of the most common services that companies have benefited from while working with Elexes are as follows:
- 510(k) Submissions
- Letter to file (LTF) for changes to existing products
- Appointment of a US Agent
- Establishment registration & listing with the US FDA
- PMA Submission
- Investigational Device Exemption (IDE)
- De Novo Submission
- Emergency Use Authorization (EUA)
- Breakthrough Device Designation (BDD)
- Review of marketing and advertising materials
- Review of publications and other materials for compliance
- Pre-submission meetings
- Technical File for CE Marking
- Health Canada MDL and MDEL
- Australian TGA approvals
- International Registrations
Quality
We provide customized quality system solutions that are tailored to your organization, because when it comes to quality systems “one size does not fit all”. Amongst the various premarket and post-market quality systems support that Elexes has provided, the following have been the most popular ones:
- Quality systems setup (ISO 13485/QSR/MDSAP)
- Document control system set up
- Validation of various software involved in the QMS
- Document Controller appointment
- Internal Audit
- Training sessions for ISO 13485, MDSAP, IEC 62304, ISO 14971
- Supplier audits & monitoring
- Managing external parties for mergers, acquisitions, and deals
- Maintenance of Quality Systems as per the ISO 13485/21 CFR Part 820/MDSAP
- FDA inspection
- Gap assessments
- Unique Device Identification (UDI)
- CAPA management
- Annual renewal of company’s registration
- Annual renewal of listing & agents
- Complaint handling & reporting
Product
Companies often get busy with product development and miss on the critical activity of documentation. However, per the requirements, if something is not documented it was never done. We help by working side by side of your design team and drafting, reviewing, and updating:
- System requirement specifications (SyRS)
- Software requirement specifications (SRS)
- Software Design Specifications (SDS)
- Software Level of Concern
- Design inputs and outputs
- Traceability Matrix
- Software Development Environment Description (SDED)
- Mobile application classification
- Risk assessment (ISO 14971)
- Shipping labels
- Instructions For Use or User Manual
- Performance protocols & reports
- Bench testing
- Third-party – IEC 60601, ISO 10993, ISO 11607, etc.
- Device History Record (DH) & Device Master Record (DMR)
- Design History File (DHF)
Clinical
The requirement of clinical evidences is rising with the rise in innovation and the advent of new regulations. The question always remains as to how much data is enough? Amongst the various clinical services that Elexes has assisted with, the following have been the most important ones:
- Due diligence to identify the need for a clinical study
- Diligence to identify the fine details for a clinical study
- Appointment of a Medical or Clinical Director
- Clinical evaluation report (CER) creation
- Clinical evaluation report (CER) updates
- Post Market Clinical Follow up (PMCF) protocol & reports
- Periodic Safety Update Reports (PSURs)
- Review of clinical data
- Clinical protocol and report per ISO 14155
- Good Clinical Practice (GCP) compliance
- Clinical operations procedures
- Scientific Publication Dashboard
- Medical and scientific content and videos
- Key Opinion Leader (KOL) engagement
- Postmarket surveillance strategy and execution
- Complaint handling and systems set up
Related Blogs
Medical device development end to end
Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessment...
Looking for an ISO 13485 Certification?
Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on t...
Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US
Ever since the boon of the healthcare industry as one of the largest industries in the world market, multiple medical device companies have been designing and developing devices that are enhanci...
