Frequently Asked Questions

Under the new Quality Management System Regulation (QMSR), the FDA has harmonized its requirements with ISO 13485:2016. While the fundamental obligation to maintain thorough, traceable documentation remains, the legacy terminology has shifted:

• Design History File (DHF) → Design and Development File (DDF): The requirement to document a device’s evolution from concept to final design now follows ISO 13485 Clause 7.3.10.
• Device Master Record (DMR) → Medical Device File (MDF): The "manufacturing blueprint" is now consolidated under the Medical Device File (Clause 4.2.3), which centralizes the specifications and procedures needed for production.
• Device History Record (DHR) → Production & Service Records: While the term DHR is no longer explicitly used in the regulation, manufacturers must still provide objective proof that each batch was manufactured and inspected in compliance with the MDF.

At Kapstone, we ensure that your existing legacy files are properly mapped to these new structures, maintaining compliance without disrupting your established workflows.

ISO 13485:2016 is the international gold standard for medical device quality management. Within this framework, Clause 7.3.8 specifically addresses design and development transfer. It requires rigorous verification that design outputs are fully suitable for manufacturing before they are released as final production specifications.

Yes. The QMSR applies to all manufacturers of finished devices intended for the U.S. market, including contract manufacturers. As a single-source partner, Kapstone maintains a QMSR-compliant environment to ensure that every stage of your product’s journey—from design transfer to full-scale production—meets these updated federal requirements.

MDD was a directive requiring transposition into each member state's law; whereas MDR is a regulation - meaning laws that apply to all member states without any transposition.

• The MDR is broader in scope and includes device categories that were previously unregulated, such as re-processed single-use devices.
• MDR re-classified many existing devices into HIGHER classifications - thus requiring more rigorous documentation requirements.
• Expansion of Technical Documentation required, including, but not limited to clinical evidence.

Learn more on our blog: Three Key Differences Between MDD and MDR.

EU MDR allows 'legacy devices' with valid MDD certificates to remain on the market until the transition deadline (2027 or 2028), provided there are no significant changes to the design or intended purpose. However, manufacturers must immediately update their Post-Market Surveillance (PMS) and vigilance reporting to meet stricter MDR standards. Learn more about Kapstone's Regulatory Affairs Services.

MDR requires a Post Market Surveillance Plan, Periodic Safety Update Report, Post Market Surveillance Report, and integration of these documents and clinical evidence into Risk Management Process.  Learn more about Kapstone's Regulatory Affairs Services. 

No, compliance with ISO 13485 alone is not enough to be compliant with the FDA's new Quality Management System Regulation (QMSR). The FDA has retained specific requirements for UDI, labeling, and MDR reporting. Learn more in our blog: FDA QMSR vs. ISO 13485.

No, certification is not required to start prototyping. However, you must implement specific Design Controls and Risk Management procedures early to ensure your prototype data is usable for future regulatory submissions.

Kapstone advises early-stage startups to implement these essential procedures immediately:
- Design & Development (ISO 13485 Cl. 7.3)
- Risk Management (ISO 14971)
- Document Control & Record Retention
- Supplier Selection / Purchasing controls

Learn more about Kapstone's Quality Assurance Services.

FDA QSR (21 CFR Part 820) is a U.S. federal regulation that medical device manufacturers must legally follow to market devices in the United States. ISO 13485, on the other hand, is an international quality management standard that provides a framework for building a medical device QMS and is required or recognized in many global markets. QSR is enforced through FDA inspections and focuses on regulatory compliance, while ISO 13485 requires third-party certification and emphasizes risk-based processes and global harmonization. Both systems cover similar concepts—such as design controls, CAPA, and production controls—but differ in structure, enforcement, and international applicability. 

A regulatory gap analysis identifies any changes to the regulations since the last implemented effort and identifies any non-conformities/deficiencies with the existing documentation in light of the regulation changes. Learn more about Kapstone's Gap Analysis Services.

The cost to commercialize a Class II 510(k) medical device typically ranges from $250,000 to over $1 million. This wide variance depends on design complexity, required clinical testing, and manufacturing startup costs. Labor for engineering, regulatory, and quality assurance typically accounts for 50% of the total budget. Learn more.

Human factors is also known as Usability is the discipline focused on designing medical devices that are safe, effective, and intuitive for users by understanding how real people interact with tools, systems, and environments. It examines how users' abilities, limitations, mistakes, and workflows can impact device safety.

Human Factors looks at:
- User interface (UI) design
- Labels and Instructions for Use
- Device displays, controls, software, connectors, alarms
- Work environments (OR, clinic, home use)
- User populations (clinicians, patients, caregivers)
- Ultimately, Human Factors ensures the device can be used safely and as intended, reducing use errors.

Testing requirements are determined by the nature and duration of body contact, as outlined in ISO 10993-1. All devices with patient contact typically require Cytotoxicity, Sensitization, and Irritation testing. Permanent implants or blood-contacting devices require more extensive testing, such as Genotoxicity, Hemocompatibility, and Implantation effects.

A Phase 0 Feasibility Study is short-term assessment of a new medical device concept which will help inform next-phase development decisions. A typical Phase 0 includes:

• Design Engineering, Technical Feasibility, and Product Manufacturability
• Regulatory Strategy
• Intellectual Property & Competitive Landscape

Kapstone's Phase 0 feasibility study deliverables are customized to the needs of each project, allowing budget and timing to scale accordingly. While some items can be completed à la carte, Kapstone strongly recommends completing the technical and engineering viability, regulatory, manufacturability, and IP assessments together to ensure a comprehensive and risk-aligned feasibility report.

• Concept Application: Assess the concept based on its intended and foreseeable clinical use. Brainstorm alternative designs.
• Design Constraints: Identify component-level risks related to items such as materials, tolerances, sealing, wear, and fatigue performance as applicable.
• Manufacturability: Ensure that Design for Manufacturability (DFM) is considered early.

There is a big difference between an early prototype and final production run.

• Cost of Goods Sold (COGS): Can this be manufactured and sold at a price point the market will support at scale?
• Material Availability: Are the raw materials readily available and do they have a history of biocompatibility?
• Supply Chain Considerations: Does the team plan to manage supply chain through a single-source point of contact like Kapstone Manufacturing, or will they have the capability to qualify and manage multiple suppliers in production?

Kapstone is one of the few MedTech firms offering a true single-source solution. After achieving market access through your regulating authority, your project seamlessly transitions to Kapstone Manufacturing for ISO 13485-certified commercial production, packaging, and supply chain management. 

• Formative evaluation is used in the early stages of the design process. These evaluations form and shape the direction of efforts, ensuring that the right device is being designed for the intended purpose.
• Summative Evaluation is used in the later stages of the development process to evaluate the end product. These evaluations summarize and explain how the device meets all of the requirements it set out to achieve regarding functionality and user interaction.

A single-source medical device partner is an integrated partner that manages the entire journey of a product from initial concept to commercial production. By integrating multi-disciplinary expertise under one roof, this model eliminates the technical and regulatory risks associated with vendor handoffs.

Kapstone’s single-source model includes:

• Product Development: Concept generation, feasibility engineering, and prototyping.

• Regulatory Affairs: FDA 510(k)/PMA strategy and global market submissions.

• Quality Assurance: Implementation of QMSR and ISO 13485-compliant systems.

• Manufacturing Solutions: Scalable ISO 13485 Contract Manufacturing through Kapstone Manufacturing.

• Commercialization Support: Launch strategy and post-market surveillance.

Design Transfer is the process by which the design team hands off a final design, documentation, and specifications (proven out by previous testing) to the manufacturing and commercialization team to bring the product to market.  Since the design of the device is considered “frozen” by this time, no more changes are anticipated prior to market launch.  Often detailed manufacturing specifications and qualifications are carried out during this phase to ensure reliable and repeatable manufacturing results down the road. Kapstone Manufacturing is a Single-Source ISO 13485 partner for the manufacturing and commercialization stages. 

Yes, Kapstone offers contract manufacturing services for all classes of products, including FDA Class III implants.