Table of Contents

Reach SOC 2 Compliance in 6 Weeks or Less.

  / Algontech Achieves ISO 13485 and CE Certifications: A Milestone in Medical Device Manufacturing

Algontech Achieves ISO 13485 and CE Certifications: A Milestone in Medical Device Manufacturing

Algontech Achieves ISO 13485 and CE Certifications 

Algontech, a distinguished leader in medical device manufacturing, proudly announces the attainment of ISO 13485 and CE certifications, marking a monumental milestone in its journey towards excellence. These esteemed certifications serve as a testament to Algontech’s steadfast dedication to delivering top-tier medical devices renowned for their quality and reliability. Algontech gets ISO 13485 and CE Certified. 

Algontech’s ISO 13485 Journey Guided by Axipro 

Algontech’s journey to ISO 13485 and CE certifications was guided by Axipro, a renowned partner in regulatory compliance and quality management systems. With Axipro’s expertise and tailored approach, Algontech navigated certification complexities seamlessly, ensuring adherence to stringent standards. Axipro’s support enabled Algontech to streamline processes, enhance efficiency, and elevate its reputation in the medical device market. Together, Algontech and Axipro epitomize collaboration and commitment to excellence, poised to deliver innovative solutions and value to healthcare providers globally. 

Why ISO 13485 Matters? 

ISO 13485 is an internationally recognized standard specifically for medical device quality management systems. Compliance with ISO 13485 plays a crucial role in ensuring the quality, safety, and regulatory compliance of medical devices. It not only demonstrates a manufacturer’s commitment to quality but also enhances product quality and safety, instills customer confidence, facilitates market access, and fosters a culture of continuous improvement. 

How Algontech Benefits from This Collaboration? 

Regulatory Compliance: 

Achieving ISO 13485 and CE certifications ensures that Algontech complies with the stringent regulatory requirements governing medical device manufacturing. This compliance not only demonstrates Algontech’s commitment to quality and safety but also opens doors to international markets by meeting the regulatory standards of various countries. 

Quality Assurance: 

With ISO 13485 certification, Algontech establishes a robust quality management system (QMS) that ensures consistent quality in its medical devices. By adhering to standardized processes and procedures, Algontech can deliver products that meet the highest standards of quality and reliability, instilling confidence in customers and stakeholders alike. 

Risk Management: 

ISO 13485 emphasizes the importance of effective risk management in medical device manufacturing. By implementing risk-based approaches throughout its operations, Algontech can identify, assess, and mitigate risks associated with product quality and safety. This proactive risk management strategy minimizes the likelihood of product recalls, regulatory issues, and adverse events, safeguarding Algontech’s reputation and market standing. 

Process Optimization: 

ISO 13485 certification encourages continuous improvement and optimization of processes within Algontech’s manufacturing operations. By adhering to standardized procedures and fostering a culture of innovation, Algontech can streamline its processes, enhance efficiency, and reduce waste. This optimization not only improves operational performance but also enhances product quality and customer satisfaction. 

Competitive Edge: 

Attaining ISO 13485 and CE certifications provides Algontech with a competitive advantage in the highly regulated medical device market. These certifications serve as a testament to Algontech’s commitment to excellence and compliance, distinguishing it from competitors and enhancing its reputation as a trusted manufacturer. This competitive edge not only attracts new customers but also strengthens relationships with existing ones, driving growth and success for Algontech in the global marketplace. 

Why Choose Axipro for ISO 13485 Certification? 

Choosing Axipro for certifications like ISO 13485 and CE offers several advantages. Axipro is renowned for its expertise in regulatory compliance and quality management systems. With a team of experienced professionals, Axipro provides comprehensive support throughout the certification process, from initial assessment to implementation and maintenance. Axipro’s tailored approach ensures that clients like Algontech receive customized solutions aligned with their unique business needs and objectives. Additionally, Axipro’s commitment to client success and satisfaction makes it the preferred partner for achieving and maintaining certifications, simplifying compliance and driving continuous improvement. 

Are you looking for your organization to get ISO 13485 certified? Contact us, we have customized packages for your requirements. Simplifying compliance: your success, our priority.

Axipro Author

Picture of Abeera Zainab

Abeera Zainab

Blog Highlights

Explore More Articles

Researchers who buy second-hand drives off online marketplaces keep finding the same thing: live data.  A widely cited study by Blancco Technology Group found that 42% of used drives sold on eBay still held recoverable information, including financial records and personal data the previous owners assumed was long gone. The drives were not hacked; they were thrown away by organizations that treated deleting a file as the same thing as destroying it. Secure data disposal is where many compliance programs fail. ISO 27001, SOC 2, and GDPR all demand it, but they describe it in different languages, enforce it through different mechanisms, and punish failure in very different ways.  This article sets out what each framework requires, where the requirements overlap, and how to run a single disposal program that satisfies all three at once. Why Secure Data Disposal Matters Across Compliance Frameworks Disposal is the last link in the data lifecycle, and the easiest one to skip. An organization can run flawless access controls, encryption, and monitoring for years and still cause a reportable breach the moment one unwiped laptop leaves the building. A recoverable drive in a recycling skip is functionally identical to an open database on the internet, and auditors and regulators know it. Most disposal failures are unforced errors: a control that was already written into policy but never carried through to the actual hardware. The gap between having a disposal policy and proving this specific drive was destroyed is exactly where audits and breach investigations live. Defining Secure Data Disposal: Key Terms and Concepts What Is Secure Data Disposal? Secure data disposal is the end-to-end process of removing data and the equipment that holds it from active use, in a way that prevents its recovery. It covers the full lifecycle end: deletion of data while a system is still live, sanitisation of media that will be reused, physical destruction of media that will not, and the safe handling of equipment that is recycled, returned to a lessor, or sold. Disposal is the goal. The methods are how you get there. What Is Secure Data Destruction? Secure data destruction is the subset of disposal that renders media permanently unusable or its contents mathematically irretrievable. Shredding a drive, pulverising it, incinerating it, or destroying the encryption keys that make an encrypted disk readable are all forms of destruction. Destruction is one route to disposal, and it is the right route when the data is highly sensitive, or the media will never be reused. Secure Data Disposal vs. Secure Data Destruction: What Is the Difference? The distinction matters more than it looks. Disposal is the outcome you owe to every framework: data gone, unrecoverable, equipment handled appropriately. Destruction is just one of the methods. You can dispose of data without destroying the hardware by sanitising a drive thoroughly enough to reuse it. Confusing the two leads to two classic mistakes: destroying assets that could have been securely wiped and reused, and assuming a quick deletion counts as disposal when it does not. Important: Emptying the recycle bin, formatting a drive, or hitting delete does not dispose of data under any of these frameworks. Standard deletion only removes the pointer to the data; the bits remain until they are overwritten. Every framework discussed here expects the data to be unrecoverable, which is a far higher bar than not visible. What ISO 27001 Requires for Secure Data Disposal ISO/IEC 27001 handles disposal through a small cluster of Annex A controls that auditors read as a single process rather than in isolation. The two controls that do most of the work are 7.14 and 8.10. For a deeper look at how these controls fit into a broader compliance program, see our ISO 27001 implementation guide. ISO 27001 Annex A 7.14: Secure Disposal or Re-Use of Equipment Annex A 7.14 is a physical control. Before any equipment is disposed of or reused, the organisation must check whether it holds information assets or licensed software and ensure those are permanently erased or the media physically destroyed. It applies to servers, laptops, desktops, mobile devices, printers, network gear, and any storage media: if it ever processed information, it is in scope. The control replaces the older 2013 clause 11.2.7 and adds explicit expectations around removing identifying markings and handling end-of-occupancy scenarios. ISO 27001 Control 8.10: Information Deletion Annex A 8.10 is a technological control, and it focuses on the data rather than the box. It requires information stored in systems, devices, or media to be deleted when it is no longer required, and rendered unrecoverable. The cleanest way to keep these straight: 8.10 governs the data while it is in use or reaches its retention limit; 7.14 governs the hardware at end of life. Most retention-driven deletion sits under 8.10; most decommissioning sits under 7.14. ISO 27001 Control 8.12: Data Leakage Prevention and Its Role in Disposal Control 8.12 is rarely filed under disposal, but improperly discarded media is one of the oldest data leakage channels there is. A drive that leaves your control with recoverable data on it is a leak, regardless of how it left. Treating disposal as part of your leakage prevention posture forces the right question at the right time: what could walk out the door on this device, and has it actually been removed? Physical Destruction and Irretrievable Erasure Under ISO 27001 ISO 27001 offers two broad routes: physically destroy media that holds information, or erase and overwrite it so retrieval by a malicious party is precluded. The standard cross-references ISO/IEC 27040 for detailed sanitisation methods. The unifying requirement is that recovery should be impractical, not merely inconvenient. Deletion alone never satisfies this. Overwriting, Full-Disk Encryption, and Other Approved Methods Overwriting user-accessible storage with multiple passes is acceptable for many sensitivity levels. Full-disk encryption changes the economics of disposal entirely: if a device is encrypted from day one and the keys are properly managed, secure disposal can be as simple as destroying the keys, a technique known as

A business continuity plan that has never been tested is, to a SOC 2 auditor, a document and nothing more. The Availability criteria do not award credit for a polished plan sitting in a shared drive. They ask for evidence that you ran the plan, watched it work or fail, recorded what happened, and fixed what broke. That gap — between having a plan and proving it works — is where most availability findings originate. Business continuity plan testing for SOC 2 is the exercise that turns your plan into auditable evidence. It maps directly to Availability criterion A1.3, one of the few SOC 2 controls that explicitly requires you to test something rather than merely document it. This guide covers what counts as a valid test, the test types auditors accept, a step-by-step process, the exact evidence you need, and the mistakes that turn a routine review into a finding. What Is Business Continuity Plan Testing in the Context of SOC 2? Business continuity plan (BCP) testing is the structured validation of whether your organization can keep critical operations running — and restore them within defined targets — during a disruption. In a SOC 2 context, the testing is not freeform. It must produce dated, traceable evidence that the recovery procedures in your plan actually work, that the people involved know their roles, and that systems and data come back within your stated recovery objectives.   Why SOC 2 Requires Business Continuity Plan Testing SOC 2 is an attestation against the AICPA’s Trust Services Criteria, and the Availability category exists specifically for organizations that make uptime or resilience commitments to customers. A plan you never exercise cannot demonstrate operating effectiveness over the audit period — which is the entire point of a Type 2 examination. Testing is the control that converts a static plan into a recurring, observable activity an auditor can sample. SOC 2 Trust Services Criteria and BCP Testing Requirements Availability is one of the five Trust Services Criteria, and it is optional, included only when your service commitments warrant it. When in scope, it is built around three sub-criteria: A1.1 addresses capacity management. A1.2 addresses recovery infrastructure and backup processes. A1.3 addresses the testing of recovery procedures. BCP testing lives squarely in A1.3, with A1.2 supplying the backups and infrastructure that the test validates. Availability Criteria A1.2 and A1.3 Explained Per the AICPA’s Trust Services Criteria, A1.2 requires the entity to design, implement, operate, and monitor environmental protections, recovery infrastructure, and data backup processes that meet its availability objectives. In plain terms: you need real backups, stored away from production, with recovery infrastructure ready to use. A1.3 then requires the entity to test recovery plan procedures supporting system recovery to meet its objectives. The two work as a pair: A1.2 builds the capability, A1.3 proves it functions. Important: The most common A1.3 gap is not a missing test. It is a test that never validated the recovery objectives. Teams run a tabletop, write “no issues found,” and move on — but the plan claims a 4-hour RTO that no one ever measured against an actual restore. If your plan states recovery targets, your test evidence must show whether you met them. A test that does not measure against your RTO and RPO leaves the most important question unanswered.   What Auditors Look for During a BCP Test Review Auditors want proof that the test happened, proof that it was meaningful, and proof that it led somewhere. Concretely, that means a test plan with a defined scenario, a dated record of execution with participants, results measured against your recovery objectives, a list of gaps or issues found, and evidence that those issues were remediated. A test that finds nothing and changes nothing is treated with suspicion — because real tests almost always surface something.   Types of Business Continuity Plan Tests Accepted for SOC 2 SOC 2 does not mandate a specific test type. It expects the rigor of the test to match the criticality of what you are protecting. The four common approaches sit on a spectrum from low-effort, low-disruption to high-effort, high-assurance. Tabletop Exercises A tabletop exercise is a facilitated discussion where key personnel talk through a disruption scenario and their responses. It is cheap, fast, and excellent for confirming that people understand their roles and that the plan reads coherently. Its limit is obvious: nobody actually recovers anything. For many organizations a tabletop is a legitimate annual test, especially in the first audit cycle, but auditors expect more rigor as a program matures. Walkthrough and Simulation Tests A simulation applies a specific scenario and asks the team to perform recovery actions, not just describe them. It is more involved than a tabletop and far better at exposing the gaps that only appear when people touch the tools. Simulations are where teams discover that a runbook references a system that was decommissioned, or that the on-call engineer lacks the access the plan assumes. Full Interruption Tests A full interruption test shuts down primary systems and shifts operations entirely to the recovery environment. It is the most comprehensive validation available and the only one that proves your failover genuinely works end to end. It also carries real operational risk, so it demands thorough planning and is usually reserved for mature programs and the most critical systems. Parallel Testing Parallel testing activates recovery systems alongside production without taking the primary offline, then compares the two to confirm the recovery environment performs as expected. It delivers much of the assurance of a full interruption test while sparing the business the disruption. For most SaaS and cloud-hosted services, parallel testing of failover and restore is the sweet spot between confidence and risk. How to Test Your Business Continuity Plan for SOC 2 Compliance The sequence below aligns with the contingency planning process in NIST’s Contingency Planning Guide, SP 800-34, which auditors widely treat as authoritative for resilience practices. Each step produces an artifact, and the artifacts together form

A SOC 2 auditor will not ask whether you have an incident reporting policy. They will ask you to pull a specific incident from the last twelve months and walk them through it: when it was detected, who classified it, when it was escalated, who was notified, and how it was closed. The policy is the easy part. The part that fails audits is the gap between what the document says and what the timestamps actually show. Incident reporting sits at the center of the SOC 2 System Operations criteria, and it is one of the most frequently exception-flagged areas in Type 2 reports. The reason is consistent: teams treat reporting as paperwork generated after the fire is out, rather than as a controlled process that produces evidence at every step. This guide breaks down how to build a reporting process that an auditor can test, sample, and sign off on without a finding. What Is the Incident Reporting Process in SOC 2? The incident reporting process is the documented, repeatable sequence your organization follows from the moment a security event is detected to the moment the incident is formally closed and archived. It governs how events are logged, classified, escalated, communicated, and recorded. Reporting is not a single notification email. It is the connective tissue that links detection, response, and post-incident review into an auditable chain. How SOC 2 Defines a Security Incident SOC 2 does not hand you a rigid statutory definition. It works through the AICPA’s Trust Services Criteria, which frame an incident around a failure, or potential failure, of the system to meet the organization’s service commitments and security objectives. In practice, a security incident is any event that compromises, or could compromise, the confidentiality, integrity, or availability of systems or data. The criteria expect you to define this threshold yourself and apply it consistently, which is precisely what auditors test against. What Qualifies as a Reportable Security Incident Under SOC 2? An event becomes reportable when it crosses the threshold your own policy sets. The distinction matters. A blocked phishing email is a security event. A user who clicked the link and entered credentials is a reportable incident. SOC 2 rewards organizations that draw this line explicitly, because a clear definition is what makes consistent triage possible. Vague language like “significant events will be reported” invites the auditor to ask who decides what counts as significant, and on what basis. Examples of Security Incidents Relevant to SOC 2 Common reportable incidents include unauthorized access to production systems, credential compromise, malware or ransomware infection, data exfiltration or accidental disclosure, denial-of-service events affecting availability, lost or stolen devices holding company data, and misconfigurations that expose data to the public. Vendor and subprocessor breaches that touch your data belong on this list, too, since the criteria extend your responsibility into the supply chain. How Incident Severity Levels Are Established and Classified Severity classification drives everything downstream: how fast you respond, who gets pulled in, and which notification clocks start ticking. Most mature programs use a tiered scheme tied to business impact rather than technical noise. The point is not the labels you choose but the fact that the labels map to defined response times and escalation paths, and that the mapping is documented before an incident occurs, not invented during one. Auditors quietly judge your maturity by how few P1s you declare and how consistently you apply the tiers. A program that labels everything critical looks panicked; one that never escalates looks asleep. The strongest signal is a severity matrix with response-time SLAs next to each tier, and ticket history showing the tiers were actually applied as written. SOC 2 Incident Reporting Requirements There is no single “incident reporting requirement” in SOC 2. The obligation is distributed across several Common Criteria, and the auditor assembles a picture from all of them. Understanding which criteria govern reporting tells you exactly what evidence to keep. Which SOC 2 Trust Services Criteria Govern Incident Reporting? Incident reporting lives mainly in the CC7 (System Operations) series. CC7.2 covers monitoring system components to detect anomalies that may signal an incident. CC7.3 requires you to evaluate detected events to determine whether they are incidents and to take action. CC7.4 governs the response itself, including containment, eradication, and communication. CC7.5 addresses recovery and remediation. Communication obligations also reach into CC2.2 and CC2.3, which deal with internal and external information flow, and third-party incidents implicate CC9.2 on vendor risk. These are points of focus, not a checklist, but auditors use them to frame their testing. For a deeper look at how these criteria map to your broader compliance program, see our SOC 2 compliance guide. What Evidence Do Auditors Expect From Your Incident Reporting Process? Auditors want artifacts with time references, not assertions. That means incident tickets showing detection and closure timestamps, severity classifications with the name of who assigned them, escalation records, communication logs, and post-incident review notes. In a Type 2 examination they will trace one real incident end to end. Evidence pulled from a staging environment, or any artifact with no clear date, gets challenged immediately. Who Is Responsible for Reporting Security Incidents? Everyone reports; a defined role decides. SOC 2 expects that all staff know how to raise a suspected incident, and that a named function, often a security lead or incident commander, owns the determination of severity and the decision to escalate. The auditor will look for evidence that this ownership is real: a RACI chart is fine, but ticket history showing the right person actually classified and closed incidents is better. Step-by-Step SOC 2 Incident Reporting Process The following sequence maps cleanly to the lifecycle in NIST’s Computer Security Incident Handling Guide (SP 800-61), which auditors widely recognize as authoritative. NIST withdrew Revision 2 in April 2025 and released Revision 3, which reorganizes the lifecycle around the six functions of the Cybersecurity Framework 2.0. The underlying steps below remain the same; the framing simply shifts toward continuous risk management.