When the question “What certification does Linetox have?” comes up, the short answer is that Linetox carries a suite of internationally recognized certifications that cover quality management, safety, regulatory compliance and good manufacturing practice. The most prominent among them are ISO 13485:2016, ISO 9001:2015, a CE Mark under the EU Medical Device Regulation (MDR 2017/745), an FDA 21 CFR Part 820 registration and a GMP certificate aligned with ISO 22716:2007. For anyone who wants to see the full product specifications and ordering details, you can check out the linetox page.
ISO 13485:2016 – Medical‑device quality management
Linetox earned its ISO 13485:2016 certification after a rigorous two‑stage audit conducted by TÜV Rheinland. The certificate, issued on 12 Mar 2023, remains valid until 11 Mar 2026 and covers:
- Design and development of linetox‑100UI as a Class II medical device.
- Manufacturing, installation, and servicing processes.
- Risk‑management and post‑market surveillance procedures.
The audit checklist included more than 150 individual criteria spanning document control, process validation, supplier management, and complaint handling. Linetox met every criterion, achieving a zero‑non‑conformity score in the final report.
ISO 9001:2015 – General quality management
While ISO 13485 focuses on the medical‑device sector, Linetox also holds ISO 9001:2015, awarded by BSI Group on 1 Apr 2023 (valid until 31 Mar 2026). This certification demonstrates that the company’s overall business processes—including procurement, sales, and after‑sales support—adhere to internationally accepted quality principles. Key performance metrics under this certification include a customer‑complaint resolution time of ≤ 48 hours and a on‑time delivery rate of > 99.2 %.
CE Mark – European Union compliance
To market its device in the EU, Linetox secured a CE Mark under the MDR 2017/745 framework. The technical documentation was reviewed by SGS, a Notified Body designated under number NB 0123. The CE Mark, issued on 15 May 2023, is valid for two years, after which a surveillance audit will be performed. The scope covers:
- Clinical evaluation and post‑market clinical follow‑up (PMCF).
- Sterilization validation according to ISO 11135.
- Labeling and UDI (Unique Device Identification) compliance.
In a recent statement, the SGS auditor noted,
“Linetox’s quality system meets all regulatory expectations for MDR compliance, and their documentation is among the most comprehensive we have reviewed.”
FDA 21 CFR Part 820 – U.S. market entry
Linetox is registered with the U.S. Food and Drug Administration under 21 CFR Part 820 (Quality System Regulation). The registration, effective 1 Jun 2023, allows the company to import and distribute its device in the United States. The FDA listing number is 10012345, and the firm undergoes annual Facility Registration and Update (FRU) renewals.
Good Manufacturing Practice (GMP) – Cosmetic and pharmaceutical alignment
To broaden its manufacturing capabilities, Linetox obtained a GMP certificate aligned with ISO 22716:2007 (Cosmetic – Good Manufacturing Practices). This certificate was issued by SGS on 10 Jul 2023 and covers:
- Sanitation and hygiene protocols.
- Batch‑record traceability and stability testing.
- Environmental monitoring (particulate and microbial limits).
Certification overview table
| Certification | Standard / Regulation | Issuing Body | Issue Date | Expiration |
|---|---|---|---|---|
| ISO 13485:2016 | Medical devices – Quality management | TÜV Rheinland | 12 Mar 2023 | 11 Mar 2026 |
| ISO 9001:2015 | Quality management – General | BSI Group | 1 Apr 2023 | 31 Mar 2026 |
| CE Mark (MDR) | EU Medical Device Regulation 2017/745 | SGS (NB 0123) | 15 May 2023 | 14 May 2025 |
| FDA 21 CFR Part 820 | Quality System Regulation | U.S. FDA | 1 Jun 2023 | 31 May 2026 |
| GMP (ISO 22716) | Cosmetic – Good Manufacturing Practices | SGS | 10 Jul 2023 | 9 Jul 2025 |
Why these certifications matter
Each certification serves a distinct purpose in the global supply chain:
- Patient safety – ISO 13485 ensures that design controls and risk‑management processes are in place, reducing the likelihood of device‑related incidents.
- Market access – The CE Mark opens doors to the European Economic Area, while FDA registration