Areas We Can Help You
MEDICAL DEVICE MANUFACTURING PROCESS VALIDATION
Drug Manufacturing (Oral/liquid dosage) Process Validation
Test Method Validation
Supplier Quality Validation
Electrical System Validation
Computer System Validation (CSV)
CAPA Owners/ Investigators
Passivation process Validation
Sterilization process Validation.
Verotech Solutions (VTS) technical operation team specializes in providing regulatory consulting services to their clients who are medical device manufacturers. We have a dedicated team working with our clients in regulatory strategy, preparation of FDA submissions, product manufacturing and testing, clinical trials set up and data collection and maintaining quality compliance.
Regulatory Services Provided:
FDA Regulatory Compliance Strategy
Premarketing Clearance 510(k) Submissions
Device Classifications and Product Listings
FDA Biocompatibility Requirements
Mock FDA Audits
Warning letter (Form 483) Responses & Activities
International Import/Export Issues
Regulations for packaging and labeling
PRODUCT DEVELOPMENT AND MANUFACTURING
Design engineers (CAD, Solid Works, Pro-E)
Kaizen/ Continuous Improvement
Statistical Process Control (SPC)
Design of Experiments (DOE)
QUALITY SYSTEM IMPLEMENTATION
All medical device-manufacturing companies in the US need to follow good manufacturing practices (GMP). Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation (QSR) of the 21 Code of Federal Regulations (CFR) Part 820. The FDA is responsible for monitoring the QSR compliance of all U.S. medical device companies.
Verotech’s Quality Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan. We will also advise and assist in developing and maintaining quality management systems and continuous improvement initiatives.
Quality System Services Provided:
GxP Training and Audits
Quality Agreement Preparation
Authoring Quality Manuals and Procedures (SOP)
Preparing Work Instructions and Process Maps
Device Master Records & Device History Records
Design History Files (DHF)
CAPA program development and implementation
Remediating compliance Support (Warning Letters, Complete Response Letters and Consent Decrees)
Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
Our pharma validation expertise:
HVAC system validation
Analytical method validation
ISO 14971:2007 or EN ISO 14971:2012 is an international standard for risk management of medical devices. The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices. The purpose of ISO 14971 is to establish, document and maintain a risk management process to:
Review the intended use of the medical device.
Identify hazards and estimate the probability that harm might occur.
Estimate the severity of each hazard and evaluate the associated risks.
Control those risks and monitor the effectiveness of the controls put in place.
Risk Assessment Services Provided:
Process Failure Mode Effects Analysis (PFMEA)
Design Failure Mode Effects Analysis (DFMEA)
Development of procedures for handling Risk
Action items and deadlines
Reduce the risk