Medical Device Consultants California

Medical Device Consultants in California

Core Compliance provides medical device consultants in California. Our consultants are based in both southern and northern California & provide flexible options for start-up medical device companies, or a comprehensive health-check for established organizations. No matter the situation, we can provide medical device consulting to ensure FDA compliance to handle each stage of medical device products, pre-market review, product control, or post market surveillance.

Get an initial free consultation for one hour to see if we can provide expertise.

Hourly Ad Hoc
Short-term
Long-term extended

California Medical Device Consulting Services

Core Compliance provides California medical device consulting services:

Education/Training-Changes and developments in the medical device industry
Road Map-Construct a strategy to and outline framework to pre-market review, product control, or post market surveillance
Conception & Development
Establish Process & Procedures, Controls
ISO Compliance-documentation requirements,Identify, Design, implement
Medical Device Product Control- Outline regulatory requirements
Submission Management
Manufacturing Facility- Inspection guidelines requirements
Packaging/Complaint Handling- Identify Evaluate outline and create or change current procedures
Software – Data management, Validation, Security
Post-market surveillance-Outlined in the quality system requirements, internal auditing

Medical Device Conception & Development

Our medical device consultants provide medical device conception & development.

Service include, Identify design control ,and testing requirements (including verification, validation and clinical trials) Safety & performance best practices, risk management practices.

Establish Process & Procedures, Controls

Core Compliance consultants establish processes, procedures and controls that meet your medical device business vision, goals and FDA, International regulatory compliance.

Legal Requirements- Identify Global and US legal requirements
Process the legalization and authentication of registration documents
Medical Device Reporting Procedures (MDR)
CAPA Management - establish a CAPA procedure early as part of an overall Quality Management System 21 CFR 820:100
Compliant Procedures- 21 CFR 820.198
Non-Conforming Product Procedures
Vendor establishment control- Vendor information facilitates governments in tracking medical device vendors

Documentation Requirements

Core Compliance medical device consultants will meet establish, design, and implement documentation requirements.

ISO Requirements-

Medical Device Products Requirements

Our regulatory consultants provide guidance for medical device products requirements, user needs, design input, design process, design output & validation.

Design Control Guidance, classification, product registration & listing-
Unique Device Identifier (UDI). Identifying mark used to distinguish devices from one another and make them easier to track Device Identifier (Type of device) Production Identifier- (serial number, expiration date, date of manufacture)
Proposed device changes

Medical Device Submission Management

We provide medical device submission management including outlining requirements based upon medical device international regulatory requirements. Prepare and obtain certificates to foreign governments, Americas- United States, Brazil Canada Columbia Mexico, EMEA (Europe, the Middle East and Africa) Egypt, Europe CE Mark, Asia Pacific, Australia, New Zealand , Peru, Russia ,Saudi Arabia ,South Africa, Turkey, China, Hong Kong, India, Singapore, South Korea, Taiwan.

Classification
Registration/Approval
Required Technical Documentation
Conformity Assessment
Declaration of conformity

Medical Device Manufacturing Facilities

Providing regulatory guidance for medical device manufacturing facilities.

Inspection guidelines requirements- FDA Registration establishments or facilities) FDA requirements
Non-Conforming devices form 483-(outlines and notifies management of any objectionable conditions found by FDA inspectors)
CGMP- quality systems for FDA-regulated products (food, drugs, biologic, and devices) are known as current good manufacturing practices (CGMP’s)

Packaging Complaint Handling

Medical device consulting includes evaluating current procedures for packaging and labeling and create cGMP compliant regulatory requirements. Packaging and labeling to medical devices is a vital part of compliance to packaging systems in delivering clean, sterile and protected medical devices. External audit to identify packaging incidents or complaints.

Medical Device Software

Core Compliance evaluate the current state of compliance fir medical device software and provide the following services:

Data management
Validation Medical Device software-outline guidelines & recommendations
Cyber-security and Risk Management processes.

Post-Market Surveillance

Core Compliance can handle all of the post market surveillance needs including:

Support International Registrations for license renewals, product changes and/or new product launches
Identify or Develop specific registration data information from applicable departments (R&D, Operations, QA, Medical,
FDA/EU substantial change notifications
Update technical files, as needed, with input from applicable departments

Represent Regulatory in product development projects by reviewing, approving, and completing requirements and coordinating team inputs for regulatory submissions. Compile and maintain regulatory documentation databases. Coordinate and respond to customer requests for product regulatory information.

ISO Standards

Core Compliance has expertise in the following ISO standards:

ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID -Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001- Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems