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This page outlines the journal-specific policies that govern manuscript evaluation, peer review, publication ethics, research integrity, reporting standards, data transparency and post-publication responsibilities.
These policies should be read together with ZENTIME's publisher-level Editorial Policies, Publishing Policies, and Open Access, Fees and Licensing policies. Where journal-specific requirements supplement publisher-level policy, authors should follow both sets of requirements unless otherwise specified.
As a journal focusing on the development, design, manufacturing, evaluation and clinical use of medical devices and related technologies, the journal covers a broad range of apparatus, machines, implants, software systems, in vitro diagnostic reagents, medical robotics, catheter devices, minimally invasive devices, diagnostic and therapeutic technologies, monitoring systems, rehabilitation devices and related translational or clinical applications. The journal requires authors to provide clear reporting of device identity, intended use, regulatory status, safety information, performance characteristics, manufacturer involvement, funding, conflicts of interest and data transparency where applicable.
The journal expects authors, editors, reviewers and editorial board members to follow internationally recognized guidelines and recommendations of responsible scholarly publishing, including relevant guidance issued by the Committee on Publication Ethics (COPE), the World Association of Medical Editors (WAME), the International Committee of Medical Journal Editors (ICMJE), and the EQUATOR Network, where applicable.
The journal operates a rigorous and consistent peer review process to ensure the quality, integrity, safety relevance and scientific value of published content.
All submitted manuscripts are first assessed by the editorial office or a handling editor for completeness, relevance to the journal's aims and scope, ethical compliance, reporting quality and suitability for further evaluation. Manuscripts that are outside the journal's scope, do not meet basic reporting standards, lack sufficient originality or raise significant ethical or safety concerns may be rejected before external peer review.
The journal uses a single-blind peer review model, in which reviewers remain anonymous to authors. Research articles, systematic reviews, clinical investigations, technical studies, device design and manufacturing studies, device evaluation studies and other scholarly manuscripts requiring external review are normally assessed by two or more independent reviewers with relevant expertise.
Reviewer comments are advisory. Final editorial decisions are made by the Editor-in-Chief or designated handling editor based on editorial assessment, reviewer comments, methodological rigor, originality, ethical compliance, regulatory and safety relevance, clinical or technical significance and suitability for the journal.
Editorials, commentaries, letters, corrections and invited content may be reviewed internally or externally at the discretion of the editors, according to the nature of the content.
The journal maintains editorial independence in all editorial decisions. Decisions on individual manuscripts are made by the Editor-in-Chief, handling editors or designated editorial decision-making team in accordance with the journal's policies.
Editorial decisions are based on scholarly merit, originality, methodological quality, relevance to the journal's aims and scope, ethical integrity, safety relevance and clinical, translational or technical contribution. Decisions are not influenced by commercial interests, advertising, sponsorship, institutional affiliation, political considerations or the financial interests of ZENTIME, journal owners, editors, editorial board members, device manufacturers or any third party.
Editors and editorial board members must maintain confidentiality, declare conflicts of interest and recuse themselves from handling manuscripts when their impartiality may be compromised. Manuscripts submitted by editors, editorial board members or journal staff will be handled independently by an editor without conflict of interest and will undergo the same editorial assessment and peer review processes as other submissions.
The journal is committed to maintaining high standards of publication ethics and research integrity. Authors, editors and reviewers are expected to act with honesty, transparency and accountability throughout the submission, review and publication process.
The journal considers plagiarism, redundant publication, duplicate submission, data fabrication, data falsification, image manipulation, citation manipulation, authorship manipulation, peer review manipulation, paper mill involvement and other forms of research or publication misconduct unacceptable.
For medical device research, authors must not misrepresent device performance, regulatory status, safety findings, adverse events, usability issues, software functions, validation results, manufacturing processes or manufacturer involvement.
Suspected misconduct will be investigated according to the journal's procedures and ZENTIME's publisher-level policies. Depending on the circumstances, outcomes may include a request for clarification, manuscript rejection, correction, expression of concern, retraction, article removal or notification of relevant institutions or authorities.
All listed authors must have made substantial scholarly contributions to the work, approved the manuscript and agreed to its submission. The corresponding author is responsible for ensuring that authorship, author order, corresponding author details and required declarations have been agreed by all authors before submission.
The journal requires an author contribution statement and encourages the use of the CRediT taxonomy where appropriate. Contributors who do not meet authorship criteria should be acknowledged with their permission.
Authors must disclose all financial and non-financial competing interests that could influence, or be perceived to influence, the work. For medical device research, relevant disclosures may include employment, consultancy, advisory roles, honoraria, stock ownership, patents, patent applications, royalties, licensing agreements, device donation or loan, sponsored testing, technical support, statistical support, writing assistance or other relationships with device manufacturers, software developers, distributors or sponsors.
All funding sources, grant numbers and institutional support should be disclosed. Authors should state the role of funders, sponsors or manufacturers in study design, device development, data collection, data access, analysis, interpretation, manuscript preparation and the decision to submit for publication.
Authors should state whether they had full access to the study data and whether the sponsor, funder or manufacturer had any role in approving or restricting publication.
Changes to authorship after submission require a clear explanation, written agreement from all authors and editorial approval.
Research involving human participants, human data or human tissue must have appropriate ethics approval or exemption. Authors should state the name of the ethics committee or institutional review board, approval number or reference, and any relevant exemption information in the manuscript.
Research involving animals must comply with applicable institutional, national and international ethical standards. Authors should provide details of ethical approval and animal welfare considerations where applicable.
Studies involving medical devices, diagnostic systems, digital health tools, software-based technologies, monitoring systems, surgical or interventional technologies, wearable devices or other device-based interventions must comply with applicable ethical, regulatory and safety requirements.
Informed consent should be obtained where required. Written consent for publication is required for identifiable patient information, clinical images, videos, case details, device-use images, imaging data, monitoring data or other personal information. Patient privacy and confidentiality must be protected, and identifying information should not be published unless essential and properly consented.
Manuscripts reporting medical device research should identify the device clearly and provide sufficient information to support evaluation, interpretation and reproducibility.
Where applicable, authors should report:
device name;
manufacturer or developer;
model, version, generation or configuration;
software or firmware version;
device classification or risk category;
intended use and indication;
regulatory status, such as approved, cleared, CE-marked, investigational, prototype, research use only or not yet approved for clinical use;
whether the device was used within or outside its approved or intended use;
whether the device was modified for the study;
relevant regulatory approval, notification, exemption or oversight, where required.
Authors should report device safety and performance outcomes transparently. This may include device-related adverse events, device deficiencies, malfunctions, usability issues, operator-related factors, failure modes, technical limitations, learning curve effects and any unexpected risks identified during the study.
For bench, preclinical, usability, engineering or performance validation studies, authors should describe the test conditions, comparator, acceptance criteria, performance endpoints, validation methods and limitations.
For studies involving investigational or high-risk devices, authors must comply with applicable institutional, national and regional regulatory requirements and should disclose relevant approvals, exemptions or oversight arrangements.
Clinical investigations and clinical trials involving medical devices should be registered in a publicly accessible registry before participant recruitment begins, where applicable. The registry name and registration number should be included in the manuscript.
Manuscripts reporting clinical trials should include a data sharing statement where required by applicable standards or journal policy. The statement should indicate whether de-identified individual participant data will be shared, what data will be shared, whether related documents such as the study protocol or statistical analysis plan will be available, when and for how long the data will be available, and the conditions for access.
Authors should follow appropriate reporting guidelines according to study design. Relevant guidelines may include CONSORT for randomized trials, CONSORT extensions where applicable, PRISMA for systematic reviews and meta-analyses, STROBE for observational studies, STARD for diagnostic accuracy studies, SPIRIT for trial protocols, TRIPOD or TRIPOD+AI for prediction model studies, CARE for case reports, ARRIVE for animal studies and other EQUATOR Network resources.
For studies of AI-enabled devices, software medical devices, digital diagnostics or clinical decision support tools, authors should report algorithm version, training and validation datasets, performance metrics, external validation, intended use, human oversight and limitations where applicable.
Reporting checklists and flow diagrams should be submitted where required by the journal or relevant reporting guideline.
Authors should include a Data Availability Statement where applicable, describing where the data supporting the findings can be accessed or explaining why data cannot be shared.
Data, materials, protocols, software, code, technical specifications and validation materials should be made available in suitable repositories where possible and appropriate. Restrictions due to privacy, ethics, legal, commercial, intellectual property, cybersecurity or safety reasons should be clearly explained.
For clinical studies, authors should ensure that shared data are appropriately de-identified and consistent with ethics approval, informed consent and applicable data protection requirements.
For device and software studies, authors should provide sufficient methodological and technical detail to allow readers and reviewers to understand the system, intervention, comparator, testing environment, data inputs, outputs, performance measures and limitations.
Supplementary materials should support the main article and should not replace essential methods, results, safety information, performance data or validation details needed to evaluate the work.
AI tools and large language models cannot be listed as authors. Authors remain responsible for the accuracy, originality and integrity of all submitted content, including any content generated or assisted by AI tools.
Use of generative AI or AI-assisted technologies beyond basic language editing should be disclosed in the manuscript according to the journal's requirements. AI tools must not be used to fabricate, falsify or manipulate data, images, references, performance results, safety findings or conclusions.
For manuscripts involving AI-enabled devices, software as a medical device, digital health technologies, diagnostic algorithms, prediction models, monitoring systems or clinical decision support tools, authors should describe the intended use, system version, development and validation methods, datasets, performance metrics, clinical workflow, human oversight, limitations and potential risks where applicable.
AI-generated or AI-assisted images, device outputs, diagnostic outputs, clinical images or visual materials should not be used unless permitted by journal policy, ethically appropriate and transparently disclosed.
Editors and reviewers must not upload confidential manuscripts, peer review reports, decision letters or related materials to public AI tools unless explicitly permitted by the journal and consistent with confidentiality and data protection requirements.
The journal considers manuscripts that have been posted as preprints, provided that the work has not been formally published and is not under consideration by another journal at the same time.
Authors must disclose any preprint, conference abstract, thesis, report, trial registry record, regulatory report or related prior dissemination at submission. Where applicable, authors should provide the preprint server name, DOI or link.
If the manuscript is accepted, authors are encouraged to update the preprint record with a citation and link to the final published article. Duplicate submission and redundant publication are not permitted.
Open Access
The journal is a Gold Open Access journal. All published articles are freely and permanently available online immediately upon publication.
Authors should review the journal's Open Access and Fees page before submission for information on article processing charges, waiver or discount options, copyright, licensing, article sharing and self-archiving.
Copyright
Authors are required to transfer copyright in their accepted manuscript to the journal upon acceptance for publication.
In exceptional circumstances, including where specific institutional or funder requirements apply, authors may contact the editorial office to discuss alternative copyright arrangements.
Licensing
All published articles are licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license.
The CC BY 4.0 license permits others to share, copy, redistribute, remix, transform and build upon the work for any purpose, including commercially, provided that appropriate credit is given to the original authors and source, a link to the license is provided, and any changes are indicated.
Article Sharing and Self-Archiving
Authors may share, host and self-archive the published Version of Record in accordance with the CC BY 4.0 license.
Articles may be shared through institutional repositories, personal websites, academic networks and other appropriate platforms, provided that appropriate attribution to the original publication is retained and the terms of the CC BY 4.0 license are respected.
Use of Third-Party and Previously Published Material
Authors are responsible for obtaining permission to reproduce or adapt material owned by third parties where permission is required. This includes material previously published by the authors themselves if the copyright is held by another publisher or third party.
Permission may be required for, including but not limited to:
previously published figures, tables, graphs, charts, schemes, artworks or other content that is reproduced or only slightly modified;
substantial extracts of text or other material from previously published works;
photographs, images or other visual materials for which the authors do not hold the necessary rights; and
the authors' own previously published material where the authors have not retained the relevant copyright or reuse rights.
Authors should obtain all necessary permissions before submitting the manuscript and provide appropriate attribution and permission statements where required.
Authors are responsible for ensuring that the use of third-party material complies with applicable copyright, license and permission requirements. Third-party material may not necessarily be covered by the CC BY 4.0 license applied to the article as a whole.
The journal is committed to maintaining the integrity and transparency of the scholarly record. Post-publication updates may include corrections, expressions of concern, retractions or article removal where appropriate.
Corrections may be issued for significant errors that do not invalidate the article. Retractions may be issued when findings are unreliable, unethical or substantially compromised. Expressions of concern may be issued when serious concerns remain unresolved.
For medical device research, post-publication concerns may include unreliable safety or performance data, undisclosed conflicts of interest, misrepresented regulatory status, unreported adverse events, invalid validation methods or other issues that may affect clinical, technical or public health interpretation.
Authors may appeal an editorial decision or submit a complaint by contacting the Editorial Office. Appeals should identify specific concerns, such as a possible error in the editorial process, a misunderstanding of the manuscript or evidence that relevant information was not adequately considered.
Appeals do not guarantee reconsideration, external review or reversal of the original decision. Repeated appeals without new evidence may not be considered. Complaints regarding editorial conduct, peer review, conflicts of interest, confidentiality or publication ethics will be handled fairly, confidentially and in a timely manner.
Related ZENTIME publisher policies:
Editorial Policies
Publishing Policies
Open Access, Fees and Licensing
Related external standards and resources may include:
Committee on Publication Ethics
World Association of Medical Editors
International Committee of Medical Journal Editors
EQUATOR Network
CONSORT
PRISMA
STROBE
STARD
SPIRIT
TRIPOD and TRIPOD+AI
CARE
ARRIVE
ISO 14155, where applicable to medical device clinical investigations
