Call Now: 925-922-9322
Compliant QMS from early phase of Product Development Cycle
Biomed QMS LLC Provides expertise in creating QMS from scratch that is applicable to class 1, 2, and 3 medical devices (class 3 devices such as drug delivery devices require especially rigorous QMS because of the high risk to patient safety).
Consulting Services for developing and implementing Quality Management Systems per FDA Regulations
Compliance to Regulations is important for 510k approval
The Quality Management System (QMS) is a must-have requirement for obtaining the launch approval for medical devices from the US Food & Drug Administration (FDA). For medical startup companies, it is difficult to develop a mature QMS that is compliant with the FDA regulations (21 CFR 820) while developing prototypes in the early phases of development.
The absence of appropriate QMS, production controls and risks to patient safety assessments can cause the repeat of verification and validation during the regulatory submissions to FDA - costing time, money, and additional delays in product launch approval (possibly 12+ months of delays).
Medical device manufacturing companies can leverage Biomed QMS LLC for hosting regulatory audits from FDA and other agencies for obtaining Manufacturing license from the State Department of Public Health.
Medical device manufacturing companies can contract their QMS project(s) to Biomed QMS LLC and avoid hiring a full-time expert of Quality & Compliance in the early phases of product development. If required, Biomed QMS LLC can assign a part-time employee for a specific project at the customer site.
Quality
-
Requirements management including identifying Critical Quality Attributes,(CQA)
-
Design Quality (Risk Management, FMEA, Usability, Reliability, Verification & Validation
-
Design Controls in Product Development Life Cycle Management)
-
Product Quality Improvement by eliminating Deviations and Nonconformance via CAPA process
-
Operation Quality (IQA, Equipment Validation (DQ/IQ/OQ/PQ)), Product release process
-
Quality Management System (QMS Per 21 CFR 820 & ISO 13485)
Supply Chain
-
Supplier Quality Management - Assessing Supplier’s quality system
-
Create supplier approval process for Approved Supplier List (ASL)
-
Manage supplier's quality via Audits and Supplier Corrective Action Report (SCAR) process
GMP Facility
-
Implement process for monitoring clean room facility environment
-
Validation of cleanliness effectiveness
-
Environmental monitoring compliant to ISO 14644
-
GMP Facility monitoring process
Compliance
-
Compliance (QSIT Audit, ISO 13485 Certification, Audit by FDA and other Regulatory Agencies)
-
California Manufacturing license from Department of Public Health
-
Support for preparing response for the 483 observations and warning letter to the FDA
-
Reinforce compliance by internal audits
Reliability
-
Perform testing based on risk and risk-based sample size for demonstrating reliability (i.e. 95%)
-
Drive reliability test conditions from the use conditions, FMEA, and VOC
-
Reliability budget for large systems
-
Drive reliability improvements based on customer returns, customer's feedback, and trending feld failures.
We're Good with establishing a Compliant Quality Management System and Risk-based approach for V&V
About Us
~
The Biomed QMS LLC Team is comprised of folks with more than a decade experience in the class 2 & 3 Medical Device Manufacturing and post-market Compliant Management and Medical Surveillance.
Client Testimonials
This page is under construction
Our Client List
~
THis page is under construction
Contact us
~
Email & Phone:
Tel: 925-922-9322
Address
3780 Hobstone Place, Dublin, CA 94568