Interpretation Services

Regulation and Standards Interpretation Service

Interpretation Service

ColabON’s experts help with standard and regulation interpretation service.

Do you have problems finding resources for standard and regulation interpretation?

We help meeting your tight timelines. Never delay a design input milestone again because of missing interpretations.

Labeling Require- ments

Our expert can write generic labeling requirements tailored to your product. These requirements consequently include all traced to GSPRs of MDR/IVDR, CFR, UDI and harmonised symbols and labeling Standards.

Furthermore, our expert can write a compliant labeling process.

Clinical Evaluation and Investigat- ion

Our expert is TüV SÜD approved trainer for MDR and EN ISO 14155:2011+AC:2011.

The service may for example include compliant process writing for clinical evaluation and clinical investigation.

Safety, effective- ness and security

Our cyber security experts are specialized in software cyber security or hardware cyber security. They consequently all have a proven track record in the field. The following standards may be part of their interpretation: IEC 80001-1:2021, IEC 82304-1:2017, SO 27000 family.

Medical Electrical Equipment

IEC 60601-1 family and GSPRs of MDR/ IVDR

Our experts evaluate for instance applicability, write generic requirements, and their acceptance criterion. Moreover, our specialists can write corresponding tests setups for these standards.

Standard and regulation data services

Do you need any further data? We can additionally deliver any standards and regulations data. Typically we aim to deliver the digitized data within a week. When the data quality allows us fast results. Please also ask for timelines to integrate any type of guidelines or internal documents and lists.

The following benefits can be achieved with the help of the software:

  • Standards & Regulations are presented as useful information in the resolution of requirements.
  • The innovative Requirement Interpretation Logic supports fast and transparent results.
  • Consistent interpretation throughout all standards and regulations.
  • Always up to date  – subscribe to the updates.

Data ready to use

The following process standards and regulations for Life Science are already fully interpreted and connected to standardized processes. You can benefit from our suggestions – or change them to your needs.

Standard NumberTitleTypeComment
(MDR) 2017/745Medical Device RegulationRegulationWith suggestions-
Also order Impact Analysis MDD / MDR
(IVDR) 2017/746In Vitro Diagnostic Medical DevicesRegulationWith suggestions – Also order Impact Analysis IVDD / IVDR
21 CFR Parts 801, 803, 820, 830, 11U.S.Code of Federal Regulation: -Medical Devices – Labeling, Reporting, Quality System Regulation, UDI, Electronic Signatures RegulationWith suggestions
MDSAP Audit ApproachAudit Guideline
ISO 9001:2015Quality management systems – RequirementsProcess StandardWith suggestions

Also Order Correlation Analysis between ISO 9001 and ISO 13485
ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)process standard
second edition
With suggestions

Also Order Correlation Analysis between ISO 9001 and ISO 13485
SN EN ISO 13485:2016/A11:2021 Amendement 11correspondence to MDR and IVDRWith suggestions

incorporated in MDR or IVDR
ISO 27001:2013Security techniques — Information security management systems — Requirementsall parts available
ISO 14971:2019 Medical devices – Application of risk management to medical devices With suggestions
EN ISO 14971:2019/A11:2021Amendement 11correspondence to MDR and IVDRWith suggestions

incorporated in MDR or IVDR

ISO/IEC GUIDE 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devicesvery helpful
ISO/TR 24971:2020Medical devices — Guidance on the application of ISO 14971very helpful
EN 62304:2006+A1:2015
Medical device software – Software life-cycle processes
EN 62366-1:2015+AC:2016 Medical devices – Application of usability engineering to medical devices 
IEC 80001-1:2011
Safety, effectiveness
and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management
EN IEC 82304-1:2017Health Software – Part 1: General requirements for product safety
EN IEC 80001-1:2011Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management
IEC TR 60601-4-5:2021Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications

Standard and Regulation Interpretation Services Description

Our standard and regulation interpretation service is a full service. That means, the service includes several steps. Hence, you can decrease your time-to-market. The following elements are part of the service:

  1. Firstly, we digitalize the content of any standard and regulation. This can also include internal documents, lists and guidelines.
  2. Secondly, our expert listens to your requirements. So they can customize the interpretation to your product type.
  3. Thirdly, we can translate your existing process architecture or product architecture in our interpretation.
  4. Fourthly, our expert assess the Applicability for each regulatory requirement. And then creates product or process requirements.
  5. Lastly, you receive a data export or you can get an access to colabON software.

Why reinvent the wheel? We translate Guidelines and Standards into useful information for your business. Use your creativity to invent great product.

ColabON AG