1. What does Eunoia Compliance do?

Eunoia Compliance is a specialized consultancy focused on the biological safety of medical devices, including biocompatibility, toxicological risk assessment, gap assessment, material safety, and particulate testing. We help you plan, interpret, and document testing so your devices meet ISO 10993, ISO 14971, MDR, FDA, and other global regulatory requirements.

2. What types of devices do you work with?

We support a broad range of medical devices across different body contact types, including:

• Intact skin devices

Non-invasive devices that contact only intact skin, such as wearables, external monitors, patches, wound dressings and CPAP interfaces (mask/cushions). These often require a focused evaluation of irritation, sensitization, and local tolerance.

• Mucosal-contact devices

Devices that contact mucosal tissues (oral, nasal, gastrointestinal, vaginal, rectal, respiratory), such as catheters, endoscopes, GI and urology devices. These typically require a broader biological safety assessment compared with intact-skin devices.

• External communicating devices – blood path

Devices that communicate externally with the cardiovascular system and contact circulating blood, such as catheters, guidewires, introducers, extracorporeal circuits, stents and certain cardiac devices. These often require detailed hemocompatibility and toxicological risk assessment.

• External communicating devices – tissue/bone

Devices that communicate with tissue or bone (e.g., orthopedic tools, surgical drills, fixation systems, certain dental devices). Here we focus on local tissue response, systemic exposure, and long-term safety, depending on the duration of contact.

• Implantable devices (short- and long-term)

Implants that remain in the body for weeks, months or permanently, including orthopedic implants, cardiovascular implants, neuromodulation devices, anchors, meshes and other long-term materials. These require a comprehensive, risk-based biocompatibility strategy, often integrating chemistry, toxicology and clinical history.

If you are unsure where your product fits, you can send a brief description (intended use, materials and body contact), and we will confirm how we can support you.

3. In which markets do you support regulatory compliance?

We support biocompatibility and biological safety projects intended for:

• European Union (EU) – including requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• United States (US) – in line with FDA regulations and guidance documents
• Other international markets that recognize or align with ISO 10993, ISO 14971, and comparable global standards

If you’re unsure how your target market’s expectations map to ISO 10993 or FDA/MDR requirements, we can help translate those requirements into a clear, practical biological evaluation strategy.

4. What is biocompatibility and why is it important?

Biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. In practice, this means your device should not cause unacceptable local or systemic adverse effects when used as intended.

Regulators expect manufacturers to plan, perform, and document a biological evaluation, typically in accordance with ISO 10993-1, to demonstrate that the clinical benefits of the device outweigh its biological risks. This evaluation is a core part of the technical documentation reviewed by authorities such as the FDA and EU Notified Bodies—and without an adequate biocompatibility assessment, a device cannot be legally placed on the market.

5. At what stage should we think about biocompatibility?

Ideally, as early as possible in the product lifecycle:

• Concept / design stage – to guide material selection, coatings, and surface treatments, and to avoid high-risk choices that may be difficult to justify later.
• Before verification & validation – to define an efficient, risk-based test strategy, align chemistry and biological testing, and avoid unnecessary or duplicative studies.
• Before regulatory submission – to compile a coherent Biological Evaluation Plan (BEP), Biological Evaluation Report (BER), and toxicological risk assessment that clearly support your submission.

Early biocompatibility planning almost always saves time, cost, and re-testing, and reduces the risk of late surprises from failed or questionable study results.

6. What services do you offer for biological safety / biocompatibility?

We support medical device manufacturers with end-to-end biological safety and biocompatibility services, including:

1.        Biocompatibility strategy and planning

a.        Biological evaluation strategies in line with ISO 10993, ISO 14971, EU MDR, and FDA guidance

b.        Authoring Biological Evaluation Plans (BEP/BEP) and Biological Evaluation Reports (BER/BSEP/BSER) 

2.        Toxicological Risk Assessment (TRA)

a.        TRAs per ISO 10993-17, based on extractables and leachables data

b.        Identification of chemicals, exposure estimation, tolerable intake (TI) and margin of safety calculations

3.        Chemical characterization support (ISO 10993-18)

a.        Interpretation of E&L and chemical characterization studies

b.        Collaboration with test labs (NAMSA, WuXi AppTec, Nelson Labs, Eurofins, UL, etc.)

4.        Biocompatibility test planning and review

a.        Selection and justification of in vitro and in vivo tests (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, etc.)

b.        GLP study design review and gap analysis against ISO 10993 series and FDA expectations 

5.        ISO 18562 / breathing gas pathway support

a.      Biocompatibility and toxicology support for devices with breathing gas pathways (e.g., capnography, respiratory devices), including test strategy and report writing under ISO 18562 

6.        Particulate and cleanliness assessments

a.        Support for particulate testing according to USP <788> and AAMI TIR42, and integration of results into the overall biological safety evaluation 

7.        Risk management and regulatory support

a.        Biological safety input into risk management files (ISO 14971)

b.        Responses to regulatory questions from FDA and Notified Bodies related to biocompatibility, chemistry, and toxicology 

8.        Compliance with hazardous substances and chemical regulations

a.   Support for REACH, RoHS, California Proposition 65, and EU MDR hazardous substances (CMRs and EDS) as they relate to material and biocompatibility assessments 

We work with Class I to Class III devices across multiple body contact types, including blood, bone, tissue, implants, and external communicating devices, and help teams turn complex data into clear, defensible biological safety justifications. 

7. Can you help if our device has already failed a biocompatibility test?

Yes. Handling failed or equivocal biocompatibility results is one of our core services.

We can help you:

• Analyze the root cause of the failure (materials, processing, test design, extraction conditions, endpoints, or data interpretation)
• Propose follow-up testing or alternative approaches, including chemistry-based and risk-based strategies
• Prepare technical memoranda and scientific justifications to support discussions with notified bodies and the FDA
• Evaluate your options and help you decide whether re-testing, design or material changes, or a risk-based justification is the most appropriate path forward

A failed test does not have to be the end of your device – it simply means the biological risk needs to be better understood, explained, and managed.

8. Do you perform testing in-house?

No. We are an independent consultancy and do not operate our own biocompatibility or particulate test laboratory.

Instead, we:

• Help you select appropriate, accredited test laboratories
• Review and optimize study protocols before testing begins
• Interpret test reports and integrate the results into your risk management and regulatory documentation

This approach keeps our advice lab-independent and ensures that recommendations are focused on what is best for your device, your timeline, and your regulatory strategy.

9. What is particulate testing of medical devices, and when is it needed?

Particulate testing evaluates the number, size, and distribution of particles that may be released from a medical device during its intended clinical use. For many devices—especially those with a liquid pathway (such as infusion sets, catheters, syringes, and IV systems)—regulators expect particulate evaluation in line with standards such as USP <788> and relevant guidance documents.

We can help you:

• Determine whether particulate testing is required for your specific device and use scenario
• Define appropriate test methods and acceptance criteria based on standards and risk
• Interpret test results in the context of patient safety, biocompatibility, and regulatory expectations

10. Can you support toxicological risk assessments (TRA)?

Yes. We support toxicological risk assessments for substances identified in chemical characterization (e.g., extractables/leachables) as well as chemicals known to be present in device materials.

Our TRA support typically includes:

• Evaluation of toxicological profiles using scientific literature and toxicology databases
• Estimation of patient exposure, both systemic and local, for short- and long-term use
• Derivation of tolerable intake values and margins of safety in line with current standards
• Clear, well-structured conclusions and documentation suitable for review by Notified Bodies and the FDA

11. How do you work with clients—what does a typical project look like?

A typical collaboration follows a clear, structured process:

1. Intro call – We discuss your device, regulatory targets, timelines, and main concerns.
2. Document review – We review your existing data, reports, risk files, and any prior submissions to understand the current state.
3. Plan – We develop a tailored biological evaluation and/or testing strategy aligned with your regulatory pathway.
4. Execution support – We assist with testing coordination, protocol review, and ongoing Q&A as studies progress.
5. Reporting – We prepare BEP, BERs, TRAs, gap assessments, and technical memoranda with clear, regulator-ready justifications.
6. Regulatory follow-up – We help you respond to questions from Notified Bodies, the FDA, or other authorities as needed.

Projects can be set up as fixed-scope (for well-defined deliverables) or time-based/retainer arrangements, depending on complexity and the level of ongoing support required.

12. Where are you based? Can you work with companies outside the U.S.?

Eunoia Compliance is based in Bar Harbor, Maine, USA, and we work with clients around the world, including Europe, North America, and other regions.

Most projects are handled remotely via email, video calls, and secure document sharing, which makes it straightforward to collaborate across different countries and time zones. When needed, we can also travel to be onsite for workshops, audits, or critical project meetings.

13. How do you handle confidentiality and NDAs?

We routinely work with confidential and proprietary information and take confidentiality very seriously. We are happy to:

• Sign your company’s Non-Disclosure Agreement (NDA), or
• Provide our own standard NDA for your review

All documents and data are handled securely, and any information you share is used solely for the purposes agreed upon in the project scope.