Compliance Management Services

Medical and IVD Device Development

Lifting medical regulatory icon overhead We offer global regulatory and product safety compliance management and testing services to electrical medical and IVD device manufacturers.

For startup firms, we offer a complete outsourcing solution for your compliance management needs. This allows you to partner for the compliance services you need, while keeping your payroll commitments down. We can fully participate in your development process, from specs to proto-types, and liaison with all necessary regulatory and safety organizations, so that you gain the approvals you need, on schedule.

For large to mid-size firms, we can augment your compliance staff, who may be stretched thin with other projects, or because of a new product line, may be encountering new issues. We offer the ability to augment any in-house testing capabilities you have, with our own testing options, allowing your test verification and validation schedules to stay on track.

In either case, because of our broad experience with product types and technologies, and international regulatory and safety requirements, we make an excellent addition to any development team. When we become a part of your development team, our focus will be on your business metrics, like time and money, but more importantly, we will be your safety partner. Your products will reach the market in compliance with local regulatory requirements, and if you've made an informed decision to do so, exceeding those requirements.

We offer services throughout your product's development life cycle:

Preparation and review of design specifications
Sourcing of components, particularly safety critical components
Risk assessments and evaluations, including suggestions for risk mitigation strategies
Use error assessments and evaluations, including suggestions for usability studies
Help with defining single-fault-safe essential performance required for acceptable risk
Design reviews of existing documents and samples for compliance with regulatory requirements
Preparation of Insulation Diagrams, documenting safety critical insulation, earthing, and impedances.
Safety verification testing of final proto-types, including preparation of IECEE CB formatted test reports to support FDA submissions, EU Technical Files, and safety certifications
Preparation and submission of FDA 510(k) packages
Help with completion of EU MDD/IVDD essential requirement checklist
Help with preparations for EU MDD/IVDD regulatory quality management system audits
Setting up and qualifying your in-house test laboratory facilities
Solutions to regulatory and safety noncompliance issues
Tagging of design specifications and drawings so that regulatory and safety critical components are properly handled by your engineering change process
Preparation of production safety testing procedures (i.e. leakage, dielectric, earthing), including sourcing of appropriate test equipment
Liaison with all regulatory and safety organizations for approvals

At OBCM we believe that compliance must be part of the design process from the start, if product development schedules are to remain on track. We encourage a proactive approach with our participation during preliminary risk assessment meetings, and later, during all design review meetings. By participating we're striving to prevent non-compliance issues, but also to provide practical training to your own staff.

However, we also understand why the ideal is not always easy to implement in the real world, especially for startup firms, who have enough to worry about to keep their functional testing on track, and therefore also their later stage venture funding. We're very familiar with this environment as well. We make it our job to help you get your first product safely to market, while helping you evolve to a more mature quality system, with a better controlled development process, for your next product.

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Software Development

We're both hardware and software safety experts. We've worked with a number of software teams developing safety critical software, for which failure could be catastrophic, including motion control systems, and X-Ray/electron beam dosage measurement systems. Safety critical software must be developed under a controlled development life cycle process. We offer services to help you:

Understand current software development requirements, such as IEC 60601-1-4, and FDA Guidance Documents, which are normally enough for EU and FDA submissions; and newer requirements defining the state of the art, including new IEC 62304.
Define and implement a compliant development life cycle process for your safety critical software
Assist with hazard identification, risk assessment, and software verification requirements
Prepare an assessment report to support FDA submissions, EU Technical Files, and safety certifications
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Test Laboratory Capabilities

obcm lab, defib-proof setup We can provide complete test reports to the IEC 60601, IEC 61010, and IEC 60950 series of standards. Our test reports can be used to satisfy the following needs:

EU CE Technical File requirements
FDA compliance documents
Customer requirements
Import clearance from other international regulatory agencies
UL, ETL, CSA, VDE, TUV, KEMA, NEMKO Certification

Or we can perform partial testing of early prototypes, where verification testing of early design options can assist early design decisions. Examples of testing we're ideally suited to deliver include:

Insulation and earthing alternatives can be compared for suitability with earthing, dielectric strength, and leakage current requirements.
Duty cycle alternatives can be compared for suitability with temperature limits.
Thermal sensor or over-current protection rating and location alternatives can be assessed.
Insulation and energy absorption alternatives for suitability with defibrillation-proof test requirements.
Mechanical stability and loading tests

For details about our test laboratory capabilities and data acceptance, see About Us page.

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Results You Can Expect

You'll get faster regulatory and safety approvals, because our participation in the regulatory and safety community since 1980 enables us to deliver. This will allow on-time production schedules, and lower development and rework costs.

Specific examples of the results you'll receive when we're a part of your development team include:

Clear explanations of conformity assessment options of EU Medical Device Directive (MDD, 93/42/EEC), or EU In Vitro Diagnostic Device Directive (IVDD, 98/79/EC), tailored to your firm's size, maturity of quality system, and time to market requirements.
Suggested improvements to quality system procedures to reduce non-compliance issues during product design, production, and post-market, and in-line with FDA and EU Notified Body expectations.
Hazard identification and state-of-the-art, cost effective risk control (mitigation) strategies.
Design input to prevent and/or work-around product safety non-compliance issues in a cost effective and timely fashion
Clear explanations of design alternatives illustrated with insulation diagrams, including discussions of pros and cons of each alternative
Techniques to integrate non-medical equipment into medical systems, saving money, and allowing state-of-the-art accessories to reach the patient
Practical ability to tag safety critical components and materials, and know minimum controls needed
Approval of in-house test facilities for supervised testing by third party certification bodies, such as UL, Intertek/ETL, CSA, VDE, TUV PS, TUV Rh, UL/Demko, Intertek/SEMKO, KEMA and many others to international test laboratory quality system requirements, ISO/IEC 17025.
Compliance with electrical medical device safety requirements of IEC 60601-1, or IEC 61010-1, including any applicable collateral and/or particular parts. Providing assessment reports, if desired.
Compliance with software development and validation requirements of IEC 60601-1-4, FDA Guidance Docs, new IEC 62304. Providing assessment reports, if desired.
Practical application knowledge of electrical medical device safety requirements, IEC 60601, and electrical IVD devices, IEC 61010, series of standards through classroom training and hands-on laboratory testing focused on your products
Practical application knowledge of the regulatory risk management driven product development life cycle process that's encouraged by FDA, the EU MDD and EU IVD, and the international standards ISO 14971 and 13485, through classroom training.

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Qualification

The About Us page has information about our firm, our quality management system, and staff qualifications, including a downloadable summary.

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Starting a Project

The Contact Us page has information about how to expedite the submittal process.

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