Strategic Services

Biomaterial Assessment

Paladin Medical® guides you in the pre-selection of biomaterials with high potential for suitability in your medical device design. There are no “FDA-approved” biomaterials, however, materials can be selected with a higher potential for successful application in medical device design. Even when a material supplier provides an FDA Master File (MAF), the information must be presented as part of the comprehensive analysis within your Biological Risk Assessment. As described in Regulatory Services, pre-clinical testing for biocompatibility according to FDA guidance documents and ISO 10993 is difficult to avoid due to requirements to test the ”final” device. But understanding qualification plays a major role in the cost of the testing and whether your test results will be accepted by the regulatory authorities. As part of your change control we also help you manage the inevitable process or supplier changes to select the best confirmatory evaluation.
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Good Laboratory Practice 21 CFR Part 58

GLP compliance (21 CFR Part 58) is NOT a suggestion! According to the GLP preamble, safety studies must follow GLPs, but “functionality studies” are considered excluded. This has been the source of confusion since device manufacturers have often argued that testing an animal-version of a medical device constitutes a “functional” evaluation and is thus exempt. Unfortunately, the draft guidance of August 28, 2013, does nothing to clarify obligations. When device manufacturers evaluate a medical device for biocompatibility, bone in-growth or potential wear; particularly when histopathology is an outcome measure, FDA typically views these studies as first and foremost: safety. You could be in for a shock if preclinical studies are submitted to FDA without a statement of compliance to Good Laboratory Practices.

Paladin Medical® will assist you in developing scientifically sound preclinical protocols for your functional animal studies that result in data to support your submission. But if you have conducted a study where GLP compliance cannot be ascertained, we will help you with methods to augment GLP-compliance deficiencies. When a study is conducted in a non-GLP certified laboratory but has met the majority of the requirements, FDA has sometimes permitted a GLP-Compliance Statement. Paladin Medical can review the lab and study management and identify the level of compliance and produce a statement of compliance, informing FDA during the review of the study, what specific deficiencies may have occurred. We employ an itemized checklist and demonstrate section by section how the study quality and facility control systems were maintained. Post-study systems auditing can be useful to demonstrate the data should be considered valid. But perhaps before a study begins, consider Paladin Medical® services if you need an adjunct Quality Assurance Unit to augment large animal facility quality program and any time you need to conduct a pre-study audit for GLP compliance.
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Forensic Regulatory Assessment is Essential for M & A

Don’t Pay for Your Merger or Acquisition Over and Over Again!

Mergers and Acquisitions within the medical device community contribute to the vitality of the industry, but far too many companies think only of forensic accounting. The newly merged company has enough to do without contending with the residual product liability and potential FDA consent decrees because no one looked at the documents in the corner! Systemic regulatory negligence is not simple to correct but at least you can factor it into your purchase agreement.

For M & As in the medical industry, a forensic regulatory assessment could identify potential gaps in medical device compliance within the quality system, documentation and marketing claims which could be passed forward to the “NEWCO.” Forensic regulatory assessment during acquisitions or mergers due diligence requires far more than “auditing” an existing quality system or going through FDA filings. Forensic regulatory reveals what is not supposed to be seen.

A successful forensic regulatory assessment involves a “look back” technique that can reveal flaws in the foundation with potential impact on the future. Regulatory forensic assessment requires the skill to identify the gaps in regulatory and engineering historical documentation and how these may affect your future. Systemic practices of benign neglect are just as damaging to the future merger or acquisition as might be overt avoidance of compliance. What the NEWCO will need to know is whether or not these deficits could be fuel for litigation and/or FDA consent decree. Your acquisition has a timetable, and you need to find these gaps fast.

Over the last decade medical device companies have been burdened with constantly changing “guidance” documents, revised interpretation of regulations, conflicting regulations between jurisdictions, and constantly revolving international standards. While chasing these changes, has the regulatory record of the candidate kept pace? Have the best decisions been made when qualifying new products or chasing down a nonconformance? Nearly all medical device products have current technology foundations built on top of old. Applications of new products in new jurisdictions place pressure on regulatory departments and even regulatory consulting companies are hard pressed to keep it all straight while meeting deadlines. Has the target of your merger or acquisition been diligent where it counts, or were shortcuts taken due to financial stress? What may linger in the record to drag your good intentions into the mire?

There are numerous examples of acquisitions where the merger was paid for again and again, long after the purchase was completed. To help you to avoid merger remorse, contact Paladin Medical, Inc. and talk about how we can help you to mitigate the regulatory risks of your new venture.
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Customized Medical Device Training

Paladin Medical® will produce and deliver customized medical device training at a level suitable for your medical device and regulatory complexity. Start-ups often require quality system procedures training to ensure uniform understanding among the various new employees. Established firms may need training as the company moves into new areas of product control. Standards are always changing, and personnel move to new responsibilities. We help you keep up with these needs at appropriate times and at the scale that you need.
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Hazard Analysis/Risk Assessment and Risk Management

Analyzing potential hazards, assessing potential risks and implementing mitigation are the backbone of medical device development and quality compliance. ISO 14971 has become the international currency of risk analysis and mitigation. FDA expects a medical device manufacturer to integrate risk management effectively throughout the lifecycle of the product. The risk management culture of a company shows through in all aspects of product and marketing management, but it starts at the development phase. Some regulatory submissions require inclusion of the risk analysis in the documentation. Paladin Medical® can guide your team through the early work of design level risk analysis and qualification planning. Integration of risk analysis into a solid Design Control and Review program is necessary for efficient and effective risk controls. Process level hazard analysis and risk mitigation is a valuable tool to determine which elements of medical device manufacturing and production may introduce risks to the user, the patient, or the quality of the device. Software and hardware risk analysis can help to isolate within the integrated requirements where risk mitigation is necessary. With complicated systems it is often necessary to assure the user can effectively perform their required role. SEE HUMAN FACTORS and USABILITY STUDIES Continual product performance monitoring through complaint monitoring and analysis systems, medical device adverse effect monitoring, and change control management are at the core of reducing risks in order to assure patient benefit. Paladin Medical provides expert services that train and enable your personnel to integrate these principles into product quality programs.
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Human Factors and Usability Studies

USER ERRORS can undermine the performance of a medical device and introduce risks. Qualification of some new medical devices (and changes) can require assessment of the user’s ability to properly employ the device as intended. It is not uncommon for a design level risk analysis to reveal intrinsic hazards associated with the use of the device, such as radiation hazards, which can be mitigated by design. But it is also true that the environment of use can contribute to risks or the interface between the device and user. Design consideration for factors related to human use (and the experience of the user) may affect the safety and performance of the device. Aspects such as design of displays and controls, interfaces with other electronic units and even the user instructions contribute to safety and performance. Our experience with these aspects of human factor design, assessment and evaluation can contribute to the work your team may undertake to assure device safety and performance in its intended use environment.
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Deciding when to submit a 510(k) to a device with an existing 510(k)

CChanges to a medical device are inevitable for safety and performance reasons, to stay abreast of competitors and simply to maintain production when a supplier is no longer suitable or available. Quality systems require that a company document changes and review, evaluate and revalidate these changes when appropriate. So, at what point might a change to a device trigger the need to make a new 510(k) application? FDA has provided ample guidance. Most international regulatory schemes stipulate when a new authorization may be necessary. Paladin Medical® can help your company work make the best determination on when a new submission is triggered and if it can be a Special 510(k). Making the determination is one task, but proper documentation of the justifications to not file is probably more important. Sometimes changes add up to create a need for re-submission, even when an individual modification did not. Your team may understand these requirements; but, may simply need a third-party review of the determination and documentation in order to feel more comfortable with the decision. With our expertise and experience we can aid your team in making the best choices and establishing sound decisions.
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Device Master File (MAF)

Companies that sell materials, components or manufacturing services should consider the benefits of a DEVICE MASTER FILE (MAF) with the Center for Devices and Radiological Health (CDRH) and you may wish to inquire if a materials supplier has a MAF with FDA. A Master File is a separate filing to FDA (no fee for filing) which holds proprietary processing and qualification information held by the material or process producer which remains “outside” of the premarket submission. Originally conceived as a means for submitting data in support of a PreMarket Approval Application (PMAA), Master Files now serve to support Investigational Device Applications, 510(k) applications and deNovo submissions. The Device Master File owner controls the content and access by FDA to the file by way of a letter to the customer. The access letter is provided by the customer to FDA as part of their submission.

Paladin Medical® can help you get started and can work with you to create this valuable asset from your existing documentation. It is important to craft the access letter so that the FDA has access to the specific information necessary to support the premarket submission at hand, and not a blanket access. The value of this access by FDA to the proprietary information about your material, quality systems and prior testing can greatly speed the approval of the candidate device and reduce the additional testing by the customer. We can also support the continual updating of the Master File and support the communication between the holder of the Master File and the customer.
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Global Regulatory Strategy

Paladin Medical® will help you think globally. If your company intends to market internationally, you need to know how your product will be regulated in these markets in order to optimize your resources. Compliance with FDA export and import regulations ensures smoother international access. Paladin Medical® assists in strategic regulatory planning and quality development planning. Knowing the global regulatory requirements and applicable conformance standards is the starting point for medical device input requirements.

We can help with:

• Global product requirements
• Exporting to regulated nations
• Import requirements for devices made outside the USA
• Applications to Competent Authority for Class I products
• Technical Documentation and Design Dossiers
• European product requirements
• Canadian, European, Australian, Latin American, and Japanese submissions, among others

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International Submissions:

We guide you in the preparation of your submissions to regulatory agencies outside USA and work with your Notified Body if you are seeking the CE Mark. Although there are common elements for most submissions each jurisdiction can have different requirements and interpretations of how standards are applied. We can author these documents and prepare your submission, working with your Foreign Representative or on-site regulatory agents. Paladin Medical® helps you integrate your Design History File with the Design Dossier and your product Device Master Record with the Technical File contents. Companies based outside the USA will find Paladin Medical® can optimize your current documentation into an FDA submission. We serve as the US Agent for clients and help with compliance with regulations such as MDR reporting, recalls, and quality systems. Looking to import to the USA? Companies based outside the USA will find Paladin Medical® can often optimize current regulatory documentation into an FDA submission when needed. We also serve as the US Agent and help with compliance with regulations such as MDR reporting, recalls, and quality systems (CFR 820). Paladin Medical® can also troubleshoot if your import is held in Customs! Read more in US Agent for Medical Device.
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U.S. Agent for Medical Device

Paladin Medical®, Inc. may serve as the U.S. Agent for clients with foreign establishments engaged in the manufacture of a medical device imported into the United States. FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. We also serve as liaison should there be a need for recall or corrective actions. We are on the look-out for any new guidance documents or regulations that may affect your products. Although the FDA does not require the U.S. agent to be responsible for Medical Device Reporting regulation (21 CFR Part 803), we can provide advice to your team, including template in-house procedures and guidance to help assure compliance with these requirements.

As a U.S. Agent we provide the required services:

• assisting FDA in communications with the foreign establishment
• responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
• assisting FDA in scheduling inspections of the foreign establishment
• serve as liaison if FDA is unable to contact the foreign establishment directly or expeditiously
• assist in registration and listing via FURLs

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Combination Products

As medical devices become more complex you may find your product has been determined to be a COMBINATION PRODUCT, even without your intent. The basis for the determination of the whether a device may be a drug, a device or a combination product centers around some basic principles generally known as “mode of action”. A combination product may include a device and drug, a device and biologic or other “combinations”. FDA provides definitions of each of these categories, but it is possible a single constituent in a device can trigger concern by FDA that the device has more than one mode of action. The Office of Combination Products (OCP) develops cross-cutting FDA guidance for product classification, jurisdiction, and criteria for determining if a device could be a COMBINATION PRODUCT. Finding out after a submission has been made that the FDA considers your new product to be a COMBINATION can set back your track to market immeasurably. With our experience and expertise, we can help you to present your argument to FDA for the determination of jurisdiction and whether or not the device has some elements which might require review as a combination product. Frequently a combination product needs a “device” regulatory expert to navigate the CDRH (Center for Devices and Radiological Health) aspects with the regulatory consultants for the Center for Biological Evaluation and Research (CBER) or CDER (Center for Drug Evaluation and Research) components. We can do that.
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