Services

It is the policy of Cadence, Inc. to provide products and services that meet or exceed our customers’ quality expectations, legal and regulatory requirements, and compliance with standards. Cadence is committed to complying with requirements, and to maintaining the effectiveness of the Quality Management System through continuous improvement.

Our quality control processes ensure compliance with industry standards and regulations:

• ISO 13485 Certification: Cadence adheres to the highest Quality Management Standards (QMS) for medical and drug delivery devices.
• Process Validation (IQ/OQ/PQ): Complete validation services, including process development, PFEMA, Measurement Systems, along with comprehensive testing to validate process performance and repeatability.
• Regulatory Compliance: We operate CFR 21 Part 820 FDA registered facilities (PA, VA, Costa Rica, RI, WI); all facilities are cGMP compliant.
• Sterilization Management: Cadence works with our OEM partners to identify the best sterilization method for your product while managing the process with a contract sterilization provider.

Cadence collaborates with our customers to solve complex challenges through the entire development process, including DFM and DFA. For early-stage products, we have the experience to produce support throughout the different phases of clinical trials as they are an essential part of developing and bringing new products safely to market.

Our Product/Process Development Services Include:

• Product Design Concept
• Design Feasibility
• Design for Manufacturing
• Prototyping
• Regulatory & Clinical
• Process Validation
• Manufacturing Transfer
• Product Lifecycle Management

Our expert team, combined with our various services, capabilities, and outstanding customer support, ensure our OEM partners’ product success.

From concept through commercialization, we support every stage of process development:

• Program Management: Cadence’s NPI process is designed to bring your innovative medical devices to market with unparalleled speed and precision, and our Program Management services are the cornerstone of successful medical device manufacturing projects.
• Design for Manufacturability (DFM): Cadence specializes in manufacturing custom products to meet the unique challenges of our OEM customers. From complex components and sub-assemblies to finished devices, we are your “single source” contract manufacturing partner, leveraging advanced technologies for difficult-to-manufacture products.
• Design for Assembly (DFA): We provide DFA to help make products easy and efficient to assemble as a part of our value-add engineering services, providing optimized assembly design, reduced costs, improved efficiencies, and long-term program success.
• Validation: As a leading Medical Device Contract Manufacturing Organization (CMO), we ensure every piece of equipment and process is meticulously validated to guarantee consistent, high-quality production. Our team prioritizes the highest standards of reliability and compliance through our comprehensive validation services, encompassing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation.

Achieve unparalleled precision and consistency with our state-of-the-art manufacturing capabilities:

• Engineering: Strong structure, discipline, and technical approach, from concept through commercialization, backed by a team of highly skilled engineers, bring products to reality that help improve patient outcomes.
• Our vertically integrated capabilities are a key driver in our end-to-end solutions.

Cadence excels in optimizing supply chain management to support the challenging needs of our MedTech and Pharma partners, allowing them to focus on their core competencies. Our integrated approach helps OEMs to:

• Focus on Core Capabilities
• Consolidate Supplier Base
• Reduce Time to Market
• Leverage External Expertise
• Reduce Total Costs

Our experts deliver high-quality, repeatable, and stable proceses through all phases of product realization, ensuring streamlined inbound logistics, customer supplied inventory, and outbound logistics.

Let us optimize your outsourcing outcomes.