Documented technical expertise
Articles are written by HSC consultants and instructors with public credentials: MDSAP lead auditors, FDA specialists and clinical evaluation PhDs. Each author's background can be verified within this website.
Editorial Process
How we produce regulatory content. With a name, source and date.
HSC Global publishes regulatory analysis that professionals use to make decisions relating to FDA, MDSAP, ANVISA, MDR and other markets. This page explains who writes our content, how we review it and when we update it.
Principles01 02 03 04
Four commitments guiding every publication.
Incorrect or outdated regulatory content can be costly for anyone registering a device or conducting an audit. Every article therefore meets criteria that apply to all authors.
Official sources as the foundation
Every regulatory statement is checked against the primary source from the competent authority (ANVISA, FDA, European Commission, Health Canada, PMDA, etc.). Resolutions, guidance and regulations are cited by their official number.
A clearly visible date
Every article displays its publication date. When a standard subsequently changes, we publish a new article announcing the change rather than editing the original. Older articles remain as a historical reference for their publication date.
Transparent authorship
No content is published anonymously. Technical team articles are credited to the HSC Global Team. External columns display the guest author's full name, area of expertise and a link to all their articles.
Our commitment
01
Every author signs their work.
02
Every source is cited.
03
Every date is visible.
Production workflow
How each article moves from briefing to publication.
The process is the same regardless of the category: MDSAP, FDA, ANVISA, MDR/IVDR or any other framework.
01
Technical briefing
Identifying the topic and author and gathering applicable official sources. Topics arise from recent regulatory changes or frequently asked client questions.
02
Expert writing
An author with relevant credentials writes the content using the primary source (regulation, guidance or ISO standard). Resolutions, regulations and standards are cited by their official number.
03
Technical team review
All content, regardless of its author, is checked by HSC's technical team. Regulatory accuracy, the currency of the referenced standard and consistency with the authority's current position are checked before publication.
04
Publication with a visible date
The article is published with its publication date, author, category and reading time. When a standard subsequently changes, we publish a new article announcing the change. The original remains a reference for that date.
Authorship
Who writes HSC Global content.
Articles are published in two formats: an institutional byline from the technical team or a guest column by an author with a PhD or internationally recognised credentials.
HSC Global Team
Most articles are collectively credited to HSC's technical team, comprising consultants and instructors working in auditing, registration and regulatory training.
- Nicolas CrispimCEO and Founder.
- Ana Carolina PazSQA Lead Auditor.
- Mariana BarreiraMDSAP Lead Auditor.
- Laura De PauliRegulatory Engineer.
Guest author columns
Guest author
Dr Juliane Rossato, PhD
Biomedical scientist, regulatory consultant and university lecturer
PhD in clinical and regulatory evaluation of medical devices. More than 15 years in clinical and pre-clinical research, ANVISA submissions and projects involving stents, TAVI and nanotechnology. Co-inventor of an international patent. FINEP/TECNOVA-RS project leader.
- PhD
- ISO 14155:2020
- MDR 2017/745
- RDC 848/2024
- 15+ years
SourcesBrazil United States European Union 5 markets National authorities Technical standards Brazilian Certification HSC operations
Where our published information comes from.
Every regulatory statement is checked against the primary source from the competent authority or standards body. Secondary references are used only to provide additional context and always clearly identify the source.
ANVISA
Resolutions, RDCs, Normative Instructions and official gov.br/anvisa portals.
FDA
Code of Federal Regulations (21 CFR), guidance and fda.gov portals.
European Commission
MDR 2017/745, IVDR 2017/746 and MDCG guidance documents.
MDSAP
The official Companion Document and Audit Approach Document.
MHRA, Health Canada, TGA, PMDA, NMPA, MFDS and CDSCO
Portals and regulations published by each country's authorities.
ISO and IEC
Current ISO 13485, ISO 14971, IEC 62366, ISO 10993 and IEC 62304 standards.
INMETRO and ANATEL
Technical ordinances for device certification in Brazil.
In-house experience
Anonymised auditing, registration and training cases from real projects.
Update
How we indicate regulatory changes.
Regulatory content ages. Rather than silently editing older articles, we retain them as a reference for the position at that date and publish new analysis whenever a standard changes.
- A clearly visible dateEvery article displays its publication date. Its information reflects the position at that time.
- New standard, new articleWhen ANVISA, the FDA or another authority publishes a significant update, we produce new analysis explaining what has changed.
- Older articles as a historical recordPublished articles remain available as a reference for the position at their publication date.
- No silent rewritingWe do not retrospectively edit older content without notice. Significant changes receive their own article.
Found an error?
Let us know. Every correction is assessed and answered.
If you identify a technical inaccuracy, an outdated standard or a broken link in any blog content, contact the editorial team. Confirmed errors are corrected and the article's review date is updated.
Contact the editorial team