Terms & Conditions

1.1 These General Terms and Conditions (“Terms”) apply to all business relationships between Zechmeister Strategic Solutions GmbH, Am Forstgarten 4/1, 9020 Klagenfurt am Wörthersee, Austria, (“Provider,” “we,” “us”) and the client (“Client,” “you”) for consulting services related to EU MDR certification, regulatory affairs, quality management systems, and related topics.

1.2 These Terms apply exclusively to business-to-business (B2B) relationships. By engaging our services, the Client confirms that it acts as an entrepreneur within the meaning of the Austrian Commercial Code (Unternehmer iSd UGB) and not as a consumer. The Provider may request suitable proof (e.g., company registration details, VAT ID) and may refuse performance if such proof is not provided.

1.3 Deviating terms and conditions of the Client shall not apply unless expressly agreed in writing.

1.4 Transparency note: These Terms may be published on our website for information purposes. The binding contractual version is the version that is provided to the Client and incorporated into the respective proposal, statement of work (“SOW”), service agreement, or other written contractual document.

1.5 If individual agreements (e.g., SOW/service agreement) contain provisions that conflict with these Terms, the following order of precedence applies unless otherwise expressly agreed:

(a) individual service agreement / master agreement, (b) SOW / proposal accepted by the Client, (c) these Terms.

1.6 “In writing” for the purposes of these Terms also includes email correspondence and digitally signed documents, unless a stricter form is required by law or explicitly agreed.

2.1 The Provider offers consulting services in the field of EU MDR certification, regulatory affairs, quality management systems, and related areas for medical device manufacturers and other business entities in the medical device ecosystem.

2.2 The specific scope of services shall be defined in individual project proposals, SOWs, or service agreements between the Provider and the Client (each a “Service Agreement”).

2.3 Our services are advisory in nature. The final decisions regarding regulatory strategy, documentation content, and submissions remain with the Client. We do not guarantee certification outcomes, as these depend on factors outside our control, including (without limitation) Notified Body decisions, authority assessments, the Client’s documentation quality, and implementation.

2.4 Unless explicitly agreed otherwise, we do not act as a legal representative before authorities or Notified Bodies, and our services do not constitute legal advice in the sense of regulated legal professions. If legal advice is required, the Client should engage qualified legal counsel.

2.5 The Provider may engage qualified subcontractors or ecosystem partners to deliver specialized aspects of the services. The Provider remains responsible for proper coordination and will ensure appropriate confidentiality obligations. If a subcontractor is intended to receive or process the Client’s confidential information beyond what is necessary, the Provider will inform the Client in advance where reasonably possible.

2.6 Timelines, milestones, and delivery dates are binding only if expressly agreed in writing. If delays are caused by missing Client cooperation, late approvals, incomplete/incorrect information, or third-party dependencies (e.g., Notified Bodies), timelines shall be extended accordingly.

3.1 Our proposals and quotations are non-binding unless otherwise stated. A contract is formed upon the Client’s written acceptance of a proposal/SOW or upon our written confirmation of the Client’s order (including by email).

3.2 Any amendments or additions to the contract must be made in writing to be valid.

3.3 The Provider reserves the right to decline engagements at its discretion, including in cases of potential conflicts of interest, compliance concerns, or capacity constraints.

3.4 Where the Provider begins performance at the Client’s request before a fully signed Service Agreement is in place, the Client agrees that these Terms shall apply from the start of performance, and the Client shall pay for services performed and costs incurred.

4.1 Fees for services shall be as specified in the individual proposal or Service Agreement. Unless otherwise agreed, fees are quoted in Euros and exclusive of applicable value-added tax (VAT).

4.2 Invoices are payable within 14 days of the invoice date, unless otherwise agreed in writing. Payment shall be made by bank transfer to the account specified on the invoice.

4.3 In case of delayed payment, the Provider is entitled to charge default interest at the statutory rate for commercial transactions under Austrian law, plus reasonable costs of collection. The Provider may also charge the statutory lump sum for collection costs where applicable.

4.4 Travel expenses, third-party costs, and other out-of-pocket expenses shall be reimbursed by the Client as agreed in the Service Agreement or upon prior written approval. Unless agreed otherwise, travel time is billable at 100% of the hourly rate.

4.5 The Provider reserves the right to require advance payment, retainer fees, or milestone payments for larger projects. The Provider may suspend performance if agreed advance/milestone payments are not made on time (without prejudice to other rights).

4.6 Set-off and retention: The Client may only set off claims against the Provider’s payment claims if the Client’s counterclaims are undisputed or finally adjudicated. The Client may only exercise rights of retention to the same extent.

5.1 The Client shall provide all information, documents, access, and decisions required for the performance of the services in a timely, complete, and accurate manner. The Client remains solely responsible for the correctness, completeness, and legal/regulatory sufficiency of information and documentation it provides.

5.2 The Client shall designate at least one qualified contact person with decision-making authority and shall ensure timely feedback, approvals, and sign-offs.

5.3 If Client cooperation is delayed or insufficient, the Provider shall not be responsible for resulting delays, additional effort, or consequences. Additional work caused by missing/incorrect information, repeated revisions due to changing instructions, or delayed approvals may be charged at the agreed rates.

6.1 Any material change of scope (“Change Request”) must be agreed in writing (including email). The Provider will inform the Client of expected impacts on fees, timelines, and resources.

6.2 Deliverables are deemed accepted if (a) the Client confirms acceptance in writing, or (b) the Client uses the deliverables productively, or (c) the Client does not raise substantial written objections within 10 business days after delivery (unless a different period is agreed in the Service Agreement). Minor defects do not prevent acceptance.

6.3 If the Client raises substantiated objections within the acceptance period, the Provider will remedy the substantiated issues within a reasonable time, provided they fall within the agreed scope.

7.1 Both parties agree to treat all confidential information received from the other party in connection with the services as strictly confidential and not to disclose it to third parties without prior written consent.

7.2 Confidential information includes, but is not limited to, technical data, business information, trade secrets, project details, financial information, and any other information marked as confidential or that should reasonably be understood to be confidential.

7.3 The confidentiality obligation shall not apply to information that: (a) is or becomes publicly available through no fault of the receiving party; (b) was already known to the receiving party prior to disclosure; (c) is independently developed by the receiving party without use of the disclosing party’s confidential information; or (d) must be disclosed by law, authority request, or court order (in which case the receiving party shall, where legally permissible, notify the disclosing party in advance).

7.4 Upon termination or upon request, each party shall return or delete the other party’s confidential information, except where retention is required by law or for legitimate documentation/defense of legal claims. Backup copies stored automatically are exempted to the extent they are not reasonably accessible for routine use.

7.5 The confidentiality obligations shall survive the termination of the contract for a period of five (5) years. Trade secrets remain protected as long as they qualify as trade secrets under applicable law.

8.1 All intellectual property rights in materials, methodologies, templates, tools, know-how, and pre-existing content provided or developed by the Provider in connection with the services (“Provider Materials”) shall remain the exclusive property of the Provider (or its licensors).

8.2 The Client is granted a non-exclusive, non-transferable, non-sublicensable license to use Provider Materials solely for its internal business purposes in connection with the project for which they were provided. Any broader use (including reuse in other projects, distribution to third parties, or publication) requires the Provider’s prior written consent unless otherwise agreed.

8.3 Work product created specifically for the Client under a Service Agreement (“Client Deliverables”) shall be made available to the Client upon full payment of all fees due. To the extent the Client Deliverables are protected by intellectual property rights, the Provider grants the Client a perpetual, worldwide, non-exclusive license for the Client’s internal business purposes. If the Service Agreement explicitly requires an exclusive transfer/assignment of rights, such assignment shall occur upon full payment of all amounts due, to the extent legally possible and to the extent the Provider owns such rights.

8.4 The Client grants the Provider a limited, non-exclusive right to use Client materials solely to perform the services.

8.5 The Provider retains the right to use general knowledge, skills, and experience acquired during the performance of services, provided that the Provider does not disclose the Client’s confidential information or trade secrets.

8.6 Case studies / references: The Provider may only use the Client’s name/logo or publish case studies (even anonymized) for marketing purposes with the Client’s prior written approval, unless the information is already publicly known through no fault of the Provider.

9.1 Each party shall comply with applicable data protection laws, including the GDPR.

9.2 To the extent the Provider processes personal data on behalf of the Client as a processor (Art. 28 GDPR) within the scope of services, the parties shall conclude an appropriate data processing agreement (“DPA”) before such processing begins. Until a DPA is concluded, the Client shall not provide personal data to the Provider for processing on its behalf beyond what is necessary for basic communication.

9.3 To the extent the Provider processes personal data as an independent controller (e.g., contact details of Client contacts for communication, invoicing, contract administration), such processing is governed by the Provider’s privacy policy and applicable law.

10.1 The Provider shall perform services with reasonable care and skill in accordance with applicable professional standards. However, we do not warrant or guarantee any specific outcomes, including but not limited to successful certification or regulatory approval.

10.2 The Provider shall be liable for damages only in cases of intent or gross negligence, except where mandatory law provides otherwise.

10.3 The limitation in 10.2 does not apply to (a) liability for death or personal injury, (b) mandatory statutory liability that cannot be excluded, or (c) claims arising from intentional breaches of confidentiality obligations.

10.4 In no event shall the Provider be liable for indirect, incidental, consequential, or punitive damages, including but not limited to loss of profits, loss of business opportunities, or business interruption, to the extent legally permissible.

10.5 The Provider’s total aggregate liability under any Service Agreement shall not exceed the total fees paid by the Client for the services giving rise to the claim, to the extent legally permissible and except for the carve-outs in 10.3.

10.6 The Client acknowledges that regulatory requirements and interpretations may change, and the Provider shall not be liable for changes in regulations or authority/Notified Body positions that affect the services or their outcomes.

10.7 The Client shall take reasonable steps to mitigate damages. Any avoidable damages shall not be recoverable.

10.8 Limitation period: Claims for damages must be asserted in writing within 12 months from the time the Client became aware (or should have become aware) of the damage and the damaging party, except for claims based on intent and claims that cannot be limited by mandatory law.

11.1 Either party may terminate the contract for convenience upon 30 days’ written notice to the other party, unless otherwise agreed in the Service Agreement.

11.2 Either party may terminate the contract with immediate effect for cause if the other party: (a) materially breaches the contract and fails to cure such breach within 14 days of written notice; (b) becomes insolvent or enters bankruptcy proceedings; or (c) ceases to carry on business.

11.3 The Provider may terminate with immediate effect if continued performance would reasonably create legal/compliance risks (e.g., sanctions, bribery concerns, severe conflicts of interest, unlawful instructions), provided the Provider has attempted in good faith to resolve the issue where reasonable.

11.4 Upon termination, the Client shall pay for all services performed up to the termination date and reimburse any non-cancellable costs incurred by the Provider in accordance with the Service Agreement.

11.5 Upon termination and subject to payment of due amounts, the Provider shall provide the Client with deliverables completed up to the termination date to the extent agreed and feasible.

11.6 The provisions regarding confidentiality, intellectual property, liability, data protection, and payment obligations shall survive termination of the contract.

12.1 Neither party shall be liable for delays or failure to perform caused by events beyond its reasonable control, including (without limitation) natural disasters, war, riots, epidemics/pandemics, strikes, governmental measures, power/internet outages, or failures of third-party systems (including Notified Bodies), provided that the affected party promptly informs the other party.

12.2 If a force majeure event continues for more than 60 days, either party may terminate the affected services with written notice. Fees for services already performed and non-cancellable costs remain payable.

13.1 These Terms and any contract between the Provider and the Client shall be governed by and construed in accordance with the laws of the Republic of Austria, excluding its conflict of laws provisions, to the extent permissible. Overriding mandatory provisions remain unaffected.

13.2 The United Nations Convention on Contracts for the International Sale of Goods (CISG) shall not apply.

14.1 The parties shall attempt to resolve any dispute arising out of or in connection with these Terms or any Service Agreement through good faith negotiations.

14.2 If the dispute cannot be resolved through negotiations within 30 days, the exclusive place of jurisdiction for all disputes shall be the competent courts of Vienna, Austria, unless mandatory law provides otherwise.

14.3 The Provider remains entitled to seek interim relief (e.g., injunctions) in any competent court, in particular to protect confidential information, intellectual property, or to secure payment claims, to the extent legally permissible.