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Compliance Management Services

Medical Device Testing, Consulting, and Training...

Testing

OBCM Laboratory Medical Device Safety and Essential Performance OBCM is foremost a test laboratory.  We perform safety and performance testing of electrical medical devices.  Other laboratories may claim to test medical devices.  We test only medical devices.  We routinely test medical devices of all types.  In addition, we have the specialized test equipment and experienced staff to allow testing of: Multifunction monitors (ECG, SpO2, Temperature, NBP, IBP),  RF equipment and accessories,   Endoscopic systems Fluid warming equipment.   We have the experienced staff to deal with the safety of complex mechanical loading and motion control systems typical with: Hospital beds,  Patient supports,  MRI systems,  Beam positioning systems, (X-Ray, electron, proton), and Laboratory assay processors. 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 See our About Us page for details about Our People, Quality System, Capabilities, Data Acceptance, Test Equipment, and Test Reports.  See our Contact Us page for details about Our Facility and how to reach us for questions or to initiate a request for quote.

OBCM Environmental Chamber 8 ft3, -41 C to 190 C, 5 to 95 %RH Chris testing a Non-Invasive Blood Pressure Monitor Dibrillation Simulator for Defibrillation-Proof Testing

Liaising for Approvals

We routinely integrate our testing services into the certification services of TUV Rheinland or UL.  We can also work with TUV SUD/Product Service, Intertek/ETL or Bureau Veritas.  We include in our fee all necessary liaison tasks, to keep things coordinated and to resolve any issues in order to keep things on schedule.  The direct 3rd party certification fees we typically don't include, rather you are invoiced directly by the 3rd party, or based on your request, we can include these 3rd party fees as part of our project fees.  Our About Us page has additional details about Our Data Acceptance.

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Consulting

Risk Management, Usability Engineering, Basic Safety, Essential Performance

We're experts with medical device safety.  Since 1996, a medical device manufacturer has been required to have an effective implementation of a quality management system, including design controls, and a post market surveillance system to allow for the improvement of the design.  Regulators now look for risk management and usability engineering (human factors) process layers to drive design requirements, and for post market surveillance to identify where improved protective measures against hazards and use errors are needed.  The international standards that describe these processes are ISO 13485, ISO 14971, and IEC 62336.

With the new 3rd edition of IEC 60601-1:2005, the international standard that forms the basis for US, European, and most other world markets' electrical medical device safety requirements, what was a test standard, has now become a process and test standard.  Risk management and usability engineering processes are required by this new device safety standard.  Safety is now known as Basic Safety, for traditional safety issues, such as degradation of electrical insulation, and insufficient enclosure strength; and Essential Performance, for the level of performance necessary to maintain acceptable risk.

We have helped many firms effectively implement these international process standards.

Medical and IVD Device Development

We offer global regulatory and product safety compliance management for 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 -- including new Machinery Directory Essential Health and Safety Requirements, which starting in March 2010 will be required for medical devices with moving parts.
• 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
• Transition from 2nd edition to 3rd edition of IEC 60601-1
• 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

See our About Us page for information about our staff and their experience.  See our Contact Us page for details about Our Facility and how to reach us for questions or to initiate a request for quote.

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Training

See our Training 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.
• Timely advise on effective dates for 3rd edition of IEC 60601-1.  Gap analysis and impact reviews for new and existing designs to comply with 3rd edition.
• 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.

Start a Project

To expedite the submittal process, please provide:

• a signed Service Agreement,
• if not using default Confidentiality clause, any separate Non-Disclosure Agreement you prefer, and
• a description of the services you'd like (project proposal or retainer terms)

All material should be sent to Contact Us.

Service Agreement

We ask all first time customers to sign a Service Agreement.  Important to us are payment terms and limited liability protection.  The agreement extends to our customers fairly standard protections for confidentiality, work product, and tax indemnity.  The agreement allows for a separate non-disclosure agreement, in lieu of the default confidentiality clause.

You may review our Service Agreement.

We're also happy to sign any Consulting or Contractor Agreement you may have.  We would ask that your agreement include payment terms and limited liability protection similar to our agreement.  We would ask that your agreement include Reusable Materials protections for our firm, similar to those included in the Work Product clause of our agreement.

Project Proposal

Each project has a project proposal defining scope, fees, and deliverables.  The customer provides a valid Purchase Order to signify agreement to proceed.

Normally OBCM will prepare a Project Proposal based on your description of the services you'd like.

• We have a monthly retainer type service when what you need is expert compliance advise on a average monthly basis.
• We compute a fixed project fee when there's a clear deliverable, such as completing a test report, or technical file.

Our Retainer Service 

We offer a monthly subscription type arrangement where by you can ask us any regulatory and safety compliance questions, or share problems with us, and we'll provide input to help resolve these questions and problems.  It's much like hiring us part time as your regulatory and compliance experts.  You pick the average hours you think you'll need monthly, and the number of months that you'd like the billing period or subscription service to extend to.  The billing rate is lower the longer the billing period. 

For example:

• A 3 month retainer for 4 h/month would be 4 h * 220 USD/h/month = 880 USD/month, billed at the end of each of 3 months. 
• A 6 month retainer for 10 h/month would be 10 h * 180 USD/h/month = 1800 USD/month, billed at the end of each of 6 months.

Formally our retainer service is described as follows:

• On a retainer basis, for xxx month period provide regulatory and safety testing and consulting services. Monthly fee is based on average yyy h/month * zzz USD/h. Maximum monthly hours not to exceed 120% of average h/month. Monthly hours in excess of maximum h/month to be billed at specified hourly rate. Not included: Third party fees, test equipment fees, and off-site services beyond 1-1/2 h drive.

If you see that you'll need our services on an ongoing basis for frequent small issues, a retainer arrangement saves us both administrative overhead with frequent quoting, obtaining Purchase Orders, and preparing Invoices.  It allows us to average and automate these processes.

Our Billing Rate

Based on your needs, our billing rate is shown in the table below.  Smaller jobs have a higher billing rate.  We find smaller jobs provide high density value to you, and as we're willing to interrupt our other work, we ask for a higher return.

If you'd like to save time, you can directly provide a valid Purchase Order for 2200 USD for a 10 h single month retainer of expert consulting services, or whatever amount you see as suitable, keeping in mind the minimum of 960 USD for a 4 h single month retainer.  Together with a signed Service Agreement, this will allow us to immediately consult.

Test Equipment Usage Fees

For most of our test equipment, our billing rate includes the overhead associated with purchasing and maintaining our test equipment.  For some large test equipment we have usage fees to help defray the costs of our investment.  The following are included in our quotes for testing, as applicable:

 

Test Equipment	Equipment Usage Fee
RF power supply (for testing RF accessories)	300 USD/day, with days rounded up to nearest whole day
Environmental Chamber (oven, humidity, refrigeration)	250 USD/day, with days rounded up to nearest whole day

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